Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects

• ClinicalTrials.gov Identifier: NCT01210352
• Recruitment Status: Completed
• First Posted: September 28, 2010
• Results First Posted: May 7, 2019
• Last Update Posted: August 20, 2021
• Sponsor: Endo Pharmaceuticals
• Information provided by (Responsible Party): Endo Pharmaceuticals

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Post Operative Pain
• Intervention: Drug: oxymorphone HCl
• Enrollment: 61

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Single Dose Phase 6 to ≤12 Years Age Group: 0.05 mg/kg	Single-Dose Phase 6 to ≤12 Years Age Group: 0.10 mg/kg	Single Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg	Single Dose Phase 2 to <6 Years Age Group: 0.05 mg/kg	Single Dose Phase 2 to <6 Years Age Group: 0.10 mg/kg	Single Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg	Single Dose Phase 0 to < 2 Years Age Group: 0.05 mg/kg	Multiple Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg	Multiple Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg
Arm/Group Description	6 to ≤12 year age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid	6 to ≤12 year age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid	6 to ≤12 year age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	2 to <6 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid	2 to <6 Years age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid	2 to <6 Years age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	0 to < 2 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid	6 to ≤12 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	2 to <6 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
Period Title: Overall Study
Started	6	6	7	7	6	6	7	10	6
Completed	6	6	5	7	6	6	5	7	2
Not Completed	0	0	2	0	0	0	2	3	4
Reason Not Completed
Adverse Event	0	0	0	0	0	0	0	2	1
Lack of Efficacy	0	0	0	0	0	0	1	0	0
Physician Decision	0	0	0	0	0	0	0	1	2
Withdrawal by Subject	0	0	1	0	0	0	1	0	1
Patient Discharged Early	0	0	1	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title		Single Dose Phase 6 to ≤12 Years Age Group: 0.05 mg/kg	Single-Dose Phase 6 to ≤12 Years Age Group: 0.10 mg/kg	Single Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg	Single Dose Phase 2 to <6 Years Age Group: 0.05 mg/kg	Single Dose Phase 2 to <6 Years Age Group: 0.10 mg/kg	Single Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg	Single Dose Phase 0 to < 2 Years Age Group: 0.05 mg/kg	Multiple Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg	Multiple Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg	Total
Arm/Group Description		6 to ≤12 year age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid	6 to ≤12 year age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid	6 to ≤12 year age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	2 to <6 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid	2 to <6 Years age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid	2 to <6 Years age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	0 to < 2 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid	6 to ≤12 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	2 to <6 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	Total of all reporting groups
Overall Number of Baseline Participants		6	6	7	7	6	6	7	10	6	61
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	6 participants	6 participants	7 participants	7 participants	6 participants	6 participants	7 participants	10 participants	6 participants	61 participants
		8.3 (1.75)	8.7 (1.86)	9.0 (2.16)	3.4 (1.27)	3.5 (1.38)	3.5 (1.38)	0.4 (0.53)	9.6 (1.90)	3.8 (1.17)	5.8 (3.56)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	7 participants	7 participants	6 participants	6 participants	7 participants	10 participants	6 participants	61 participants
	Female	1 16.7%	2 33.3%	6 85.7%	2 28.6%	3 50.0%	6 100.0%	1 14.3%	5 50.0%	0 0.0%	26 42.6%
	Male	5 83.3%	4 66.7%	1 14.3%	5 71.4%	3 50.0%	0 0.0%	6 85.7%	5 50.0%	6 100.0%	35 57.4%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	7 participants	7 participants	6 participants	6 participants	7 participants	10 participants	6 participants	61 participants
	Hispanic or Latino	0 0.0%	0 0.0%	1 14.3%	0 0.0%	0 0.0%	2 33.3%	0 0.0%	0 0.0%	0 0.0%	3 4.9%
	Not Hispanic or Latino	6 100.0%	6 100.0%	6 85.7%	7 100.0%	6 100.0%	4 66.7%	7 100.0%	10 100.0%	6 100.0%	58 95.1%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	6 participants	7 participants	7 participants	6 participants	6 participants	7 participants	10 participants	6 participants	61 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	1 14.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 1.6%
	Asian	0 0.0%	2 33.3%	0 0.0%	0 0.0%	1 16.7%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	3 4.9%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	2 33.3%	1 16.7%	0 0.0%	3 42.9%	1 16.7%	0 0.0%	1 14.3%	3 30.0%	1 16.7%	12 19.7%
	White	4 66.7%	3 50.0%	6 85.7%	4 57.1%	4 66.7%	6 100.0%	6 85.7%	7 70.0%	5 83.3%	45 73.8%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Weight; Mean (Standard Deviation); Unit of measure: Kg
	Number Analyzed	6 participants	6 participants	7 participants	7 participants	6 participants	6 participants	7 participants	10 participants	6 participants	61 participants
		35.25 (11.725)	30.33 (17.731)	37.26 (20.613)	18.76 (4.026)	15.77 (4.303)	17.88 (4.869)	9.10 (3.106)	41.81 (18.103)	17.83 (2.701)	25.84 (16.311)

Outcome Measures

1. Primary Outcome

Title	Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase
Description	Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 years and 0 years to < 2 years age groups, (0 = no pain and 10 = very much pain).
Time Frame	Baseline, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose; and at the time of rescue

Outcome Measure Data

Analysis Population Description

Effectiveness Population. The analyses performed for this study report did not differentiate the pain intensity and pain intensity difference by age/dose combination.

The analyses were conducted by age group alone and results are presented accordingly.

Arm/Group Title		6 Years to ≤ 12 Years Age Group in Single Dose Phase	2 Years to < 6 Years Age Group in Single Dose Phase	0 Years to < 2 Years Age Group in Single Dose Phase
Arm/Group Description:		Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 year age group	Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to < 2 years age group
Overall Number of Participants Analyzed		19	19	7
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline (Prior to Treatment)	Number Analyzed	19 participants	19 participants	7 participants
		4.5 (3.12)	3.4 (3.55)	2.4 (1.90)
15 Minutes Post Dose	Number Analyzed	19 participants	18 participants	7 participants
		3.5 (3.64)	1.2 (2.50)	1.3 (2.63)
30 Minutes Post Dose	Number Analyzed	18 participants	18 participants	7 participants
		2.7 (3.29)	1.2 (2.28)	0.4 (0.79)
1 Hour Post Dose	Number Analyzed	18 participants	17 participants	7 participants
		1.8 (1.93)	0.2 (0.56)	0.1 (0.38)
1.5 Hours Post Dose	Number Analyzed	12 participants	11 participants	0 participants
		2.0 (2.56)	0.2 (0.60)
2 Hours Post Dose	Number Analyzed	15 participants	16 participants	7 participants
		3.1 (3.37)	0.4 (0.81)	0.4 (0.79)
3 Hours Post Dose	Number Analyzed	4 participants	3 participants	7 participants
		0.0 (0.00)	2.0 (2.65)	0.4 (1.13)
4 Hours Post Dose	Number Analyzed	12 participants	11 participants	6 participants
		1.8 (2.17)	1.5 (2.34)	1.3 (1.51)
6 Hours Post Dose	Number Analyzed	7 participants	9 participants	4 participants
		2.3 (1.80)	0.7 (1.41)	0.8 (1.50)
8 Hours Post Dose	Number Analyzed	3 participants	8 participants	3 participants
		3.3 (5.77)	0.8 (1.39)	0.0 (0.00)
12 Hours Post Dose	Number Analyzed	3 participants	6 participants	3 participants
		1.3 (2.31)	0.0 (0.00)	0.0 (0.00)
24 Hours Post Dose	Number Analyzed	0 participants	4 participants	2 participants
			0.0 (0.00)	0.0 (0.00)

2. Primary Outcome

Title	Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase
Description	Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 years and 0 years to < 2 years age groups, (0 = no pain and 10 = very much pain). PID was calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point.
Time Frame	Baseline (prior to dose); 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose; and at the time of rescue

Outcome Measure Data

Analysis Population Description

Effectiveness Population. The analyses performed for this study report did not differentiate the pain intensity and pain intensity difference by age/dose combination.

The analyses were conducted by age group alone and results are presented accordingly.

Arm/Group Title		6 Years to ≤ 12 Years Age Group in Single Dose Phase	2 Years to < 6 Years Age Group in Single Dose Phase	0 Years to < 2 Years Age Group in Single Dose Phase
Arm/Group Description:		Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 year age group	Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to < 2 year age group
Overall Number of Participants Analyzed		19	19	7
Mean (Standard Deviation); Unit of Measure: score on a scale
15 Minutes Post-Dose	Number Analyzed	19 participants	18 participants	7 participants
		1.1 (4.24)	2.1 (2.56)	1.1 (4.06)
30 Minutes Post-Dose	Number Analyzed	18 participants	18 participants	7 participants
		1.6 (3.33)	2.1 (2.49)	2.0 (2.45)
1 Hour Post-Dose	Number Analyzed	18 participants	17 participants	7 participants
		2.4 (3.67)	2.6 (3.10)	2.3 (1.98)
1.5 Hours Post-Dose	Number Analyzed	12 participants	11 participants	0 participants
		3.0 (3.86)	3.8 (3.84)
2 Hours Post-Dose	Number Analyzed	15 participants	16 participants	7 participants
		1.5 (4.03)	2.6 (3.40)	2.0 (2.45)
3 Hours Post-Dose	Number Analyzed	4 participants	3 participants	7 participants
		3.0 (2.00)	-1.0 (2.00)	2.0 (2.31)
4 Hours Post-Dose	Number Analyzed	12 participants	11 participants	6 participants
		2.7 (4.21)	2.5 (3.24)	1.0 (2.83)
6 Hours Post-Dose	Number Analyzed	7 participants	9 participants	4 participants
		3.1 (4.14)	3.0 (2.40)	1.0 (2.71)
8 Hours Post-Dose	Number Analyzed	3 participants	8 participants	3 participants
		1.3 (2.31)	2.4 (2.92)	1.7 (2.89)
12 Hours Post-Dose	Number Analyzed	3 participants	6 participants	3 participants
		3.3 (5.77)	3.2 (2.32)	1.7 (2.89)
24 Hours Post-Dose	Number Analyzed	0 participants	4 participants	2 participants
			3.0 (2.16)	0.0 (0.00)

3. Primary Outcome

Title	Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase
Description	Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 years and 0 years to < 2 years age groups, (0 = no pain and 10 = very much pain)
Time Frame	Baseline, 0.5, 1, 1.5, 2, hours post dose, and immediately prior to all remaining doses administered through 48 hours after administration of the initial dose; and at time of rescue

Outcome Measure Data

Analysis Population Description

Effectiveness Population. Based on the recommendation of the Independent Data Monitoring Committee (IDMC), there was only 1 dose group of 0.2 mg/kg administered during the Multiple-dose Phase. Thus, this outcome measure was only assessed in this dose group.

Arm/Group Title		6 Years to ≤ 12 Years Age Group in Multiple Dose Phase	2 Years to < 6 Years Age Group in Multiple Dose Phase
Arm/Group Description:		Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 year age group
Overall Number of Participants Analyzed		10	6
Mean (Standard Deviation); Unit of Measure: score on a scale
Dose 1, Baseline (Prior to Treatment)	Number Analyzed	9 participants	6 participants
		3.1 (2.67)	3.5 (3.27)
Dose 1, 30 Minutes Post Dose	Number Analyzed	9 participants	6 participants
		2.7 (1.73)	1.3 (1.97)
Dose 1, 1 Hour Post Dose	Number Analyzed	10 participants	5 participants
		2.0 (2.83)	1.8 (2.05)
Dose 1, 1.5 Hours Post Dose	Number Analyzed	8 participants	4 participants
		2.3 (1.67)	0.0 (0.00)
Dose 1, 2 Hours Post Dose	Number Analyzed	8 participants	4 participants
		2.8 (2.38)	0.0 (0.00)
Dose 2, 0 Hour	Number Analyzed	7 participants	3 participants
		4.0 (3.27)	5.0 (2.65)
Dose 3, 0 Hour	Number Analyzed	5 participants	3 participants
		5.6 (2.61)	3.7 (3.21)
Dose 4, 0 Hour	Number Analyzed	6 participants	2 participants
		4.0 (3.58)	4.5 (0.71)
Dose 5, 0 Hour	Number Analyzed	4 participants	2 participants
		2.5 (1.00)	5.0 (0.00)
Dose 6, 0 Hour	Number Analyzed	4 participants	1 participants
		2.5 (1.00)	6.0 [1] (NA)
Dose 7, 0 Hour	Number Analyzed	4 participants	0 participants
		3.0 (2.00)
Dose 8, 0 Hour	Number Analyzed	3 participants	0 participants
		4.7 (2.31)
Dose 9, 0 Hour	Number Analyzed	3 participants	0 participants
		1.3 (1.15)
Dose 10, 0 Hour	Number Analyzed	3 participants	0 participants
		2.0 (0.00)
Dose 11, 0 Hour	Number Analyzed	2 participants	0 participants
		2.0 (0.00)
Dose 12, 0 Hour	Number Analyzed	2 participants	0 participants
		5.0 (4.24)
End of Study/Early Termination	Number Analyzed	4 participants	4 participants
		4.0 (1.63)	1.3 (2.50)

[1]

SD cannot be derived based on one subject data point

4. Primary Outcome

Title	Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase
Description	Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 years and 0 years to < 2 years age groups, (0 = no pain and 10 = very much pain). PID is calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point.
Time Frame	0.5, 1, 1.5, 2, hours post dose 1 through to Dose 12, 0 Hour; End of Study/Early Termination

Outcome Measure Data

Analysis Population Description

Effectiveness Population.IDMC recommended dose: 0.20 mg/kg oxymorphone HCl oral solution for the Multiple-dose Phase. Therefore, the analyses were conducted in a total of 16 subjects ranging from 2 to ≤12 years who received the dose of 0.20 mg/kg oxymorphone HCl oral solution as shown in the table of baseline characteristic in the participant flow.

Arm/Group Title		6 to ≤12 Years Age Group: 0.20 mg/kg	2 to <6 Years Age Group: 0.20 mg/kg
Arm/Group Description:		Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to < 6 year age group
Overall Number of Participants Analyzed		10	6
Mean (Standard Deviation); Unit of Measure: score on a scale
Dose 1, 30 Minutes Post-Dose	Number Analyzed	9 participants	6 participants
		0.4 (2.19)	2.2 (2.79)
Dose 1, 1 Hour Post-Dose	Number Analyzed	9 participants	5 participants
		0.9 (2.67)	2.0 (3.46)
Dose 1, 1.5 Hours Post-Dose	Number Analyzed	7 participants	4 participants
		1.1 (3.02)	4.8 (3.30)
Dose 1, 2 Hours Post-Dose	Number Analyzed	8 participants	4 participants
		0.0 (1.85)	4.8 (3.30)
Dose 2, 0 Hour	Number Analyzed	6 participants	3 participants
		-2.3 (3.88)	0.3 (1.53)
Dose 3, 0 Hour	Number Analyzed	4 participants	3 participants
		-3.5 (4.43)	1.7 (0.58)
Dose 4, 0 Hour	Number Analyzed	5 participants	2 participants
		-0.8 (3.03)	3.0 (1.41)
Dose 5, 0 Hour	Number Analyzed	4 participants	2 participants
		1.0 (1.15)	2.5 (0.71)
Dose 6, 0 Hour	Number Analyzed	4 participants	1 participants
		1.0 (2.58)	2.0 [1] (NA)
Dose 7, 0 Hour	Number Analyzed	4 participants	0 participants
		0.5 (2.52)
Dose 8, 0 Hour	Number Analyzed	3 participants	0 participants
		-2.0 (2.00)
Dose 9, 0 Hour	Number Analyzed	3 participants	0 participants
		2.7 (1.15)
Dose 10, 0 Hour	Number Analyzed	3 participants	0 participants
		2.0 (2.00)
Dose 11, 0 Hour	Number Analyzed	2 participants	0 participants
		3.0 (1.41)
Dose 12, 0 Hour	Number Analyzed	2 participants	0 participants
		0.0 (5.66)
End of Study/Early Termination	Number Analyzed	4 participants	4 participants
		-0.5 (1.91)	3.5 (3.11)

[1]

Not determined, or not reported due to insufficient data for reliable estimate

5. Primary Outcome

Title	Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase
Description	Rescue Medication Use in Multiple Dose Phase
Time Frame	Rescue Medication Use

Outcome Measure Data

Analysis Population Description

Effectiveness Population.IDMC recommended dose: 0.20 mg/kg oxymorphone HCl oral solution for the Multiple-dose Phase. Therefore, the analyses were conducted in a total of 16 subjects ranging from 2 to ≤12 years who received the dose of 0.20 mg/kg oxymorphone HCl oral solution as shown in the table of baseline characteristic in the participant flow.

Arm/Group Title	6 to ≤12 Years Age Group: 0.20 mg/kg	2 to <6 Years Age Group: 0.20 mg/kg
Arm/Group Description:	Percentages are based on the number of subjects ('N') in effectiveness population in each dose group in each age group in Multiple-Dose Phase	Percentages are based on the number of subjects ('N') in effectiveness population in each dose group in each age group in Multiple-Dose Phase
Overall Number of Participants Analyzed	10	6
Measure Type: Count of Participants; Unit of Measure: Participants
Rescue Medication Used	5 50.0%	2 33.3%
No Rescue Medication needed	5 50.0%	4 66.7%

6. Secondary Outcome

Title	Oxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Overall Number of Participants Analyzed	6	7	6	6	7	6
Mean (Standard Deviation); Unit of Measure: ng/mL
	0.415 (0.211)	0.33 (0.217)	1.14 (0.847)	1.76 (1.62)	1.33 (0.772)	3.16 (1.65)

7. Secondary Outcome

Title	Oxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	Tmax: The time at which Cmax was observed
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed
Overall Number of Participants Analyzed	6	7	6	6	7	6
Mean (Standard Deviation); Unit of Measure: h
	2.7 (1.66)	2.64 (1.03)	1.38 (1.3)	1.45 (1.39)	2.49 (3.17)	1.59 (1.38)

8. Secondary Outcome

Title	Oxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Overall Number of Participants Analyzed	6	7	6	6	7	6
Mean (Standard Deviation); Unit of Measure: ng/mL
	0.0759 (0.072)	0.0618 (0.0389)	0.11 (0.0847)	0.0671 (0.0376)	0.269 (0.182)	0.645 (1.3)

9. Secondary Outcome

Title	Oxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	Tlast: The time at which Clast was observed
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed
Overall Number of Participants Analyzed	6	7	6	6	7	6
Mean (Standard Deviation); Unit of Measure: h
	15.4 (7.01)	13.2 (5.06)	18 (6.55)	16 (8.04)	12.6 (9.85)	18.4 (8.97)

10. Secondary Outcome

Title	Oxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Overall Number of Participants Analyzed	6	7	6	6	7	6
Mean (Standard Deviation); Unit of Measure: h*ng/mL
	2.56 (2)	1.69 (0.943)	3.01 (0.766)	3.99 (2.09)	5.32 (4.53)	9.37 (5.81)

11. Secondary Outcome

Title	Oxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Overall Number of Participants Analyzed	2	2	2	3	3	2
Mean (Standard Deviation); Unit of Measure: h*ng/mL
	NA [1] (0.0516)	3.22 (1.56)	3.01 (0.946)	3.69 (3.12)	6.92 (4.02)	14.3 (5.01)

[1]

Not determined, or not reported due to insufficient data for reliable estimate

12. Secondary Outcome

Title	Oxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Overall Number of Participants Analyzed	3	3	4	4	4	2
Mean (Standard Deviation); Unit of Measure: h*ng/mL
	3.75 (2.32)	2.65 (1.4)	3.01 (0.905)	3.69 (2.44)	6.11 (2.83)	14 (4.72)

13. Secondary Outcome

Title	Oxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	t1/2: Terminal half-life, calculated as λn/(ln 2)
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)
Overall Number of Participants Analyzed	2	2	2	3	3	2
Mean (Standard Deviation); Unit of Measure: h
	NA [1] (0.232)	5.01 (1.4)	7.5 (7.33)	4.38 (2.9)	5.13 (3.16)	4.39 (1.16)

[1]

Not determined, or not reported due to insufficient data for reliable estimate

14. Secondary Outcome

Title	Dose-Normalized Oxymorphone CL/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the CL/F.

Arm/Group Title	Combined 0.05, 0.1, and 0.2 mg/kg - Aged 6 Years to ≤ 12 Years	Combined 0.05, 0.1, and 0.2 mg/kg - Aged 2 Years to <6 Years
Arm/Group Description:	CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf	CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
Overall Number of Participants Analyzed	7	7
Mean (Standard Deviation); Unit of Measure: L/h/kg
	31.2 (13.6)	26.4 (18.8)

15. Secondary Outcome

Title	Dose-Normalized Oxymorphone V/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the V/F.

Arm/Group Title	Combined 0.05, 0.1, and 0.2 mg/kg - Aged 6 Years to ≤ 12 Years	Combined 0.05, 0.1, and 0.2 mg/kg - Aged 2 Years to <6 Years
Arm/Group Description:	V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)	V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
Overall Number of Participants Analyzed	7	7
Mean (Standard Deviation); Unit of Measure: L/kg
	205 (145)	154 (121)

16. Secondary Outcome

Title	Oxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Cmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Overall Number of Participants Analyzed	10	5	3	0
Mean (Standard Deviation); Unit of Measure: ng/mL
	1.46 (1.16)	2.58 (1.24)	2.66 (0.805)

17. Secondary Outcome

Title	Oxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	Tmax: The time at which Cmax was observed
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed
Overall Number of Participants Analyzed	10	5	3	0
Mean (Standard Deviation); Unit of Measure: h
	1.37 (0.599)	0.967 (0.622)	1.21 (1.1)

18. Secondary Outcome

Title	Oxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Clast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Overall Number of Participants Analyzed	10	5	3	0
Mean (Standard Deviation); Unit of Measure: ng/mL
	0.452 (0.286)	0.508 (0.32)	2.3 (0.745)

19. Secondary Outcome

Title	Oxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	Tlast: The time at which Clast was observed
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tlast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed
Overall Number of Participants Analyzed	10	5	3	0
Mean (Standard Deviation); Unit of Measure: h
	4 (0.971)	4.47 (1.68)	2.09 (0.077)

20. Secondary Outcome

Title	Oxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of AUC0-t was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Overall Number of Participants Analyzed	10	5	3	0
Mean (Standard Deviation); Unit of Measure: h*ng/mL
	3.49 (3.22)	3.88 (1.45)	4.24 (0.9)

21. Secondary Outcome

Title	Oxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Overall Number of Participants Analyzed	3	3	0	0
Mean (Standard Deviation); Unit of Measure: h*ng/mL
	4.01 (1.43)	4.53 (2.21)

22. Secondary Outcome

Title	Oxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Overall Number of Participants Analyzed	3	3	0	0
Mean (Standard Deviation); Unit of Measure: h*ng/mL
	4.01 (1.42)	4.53 (2.21)

23. Secondary Outcome

Title	Oxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	t1/2: Terminal half-life, calculated as λn/(ln 2)
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)
Overall Number of Participants Analyzed	3	3	0	0
Mean (Standard Deviation); Unit of Measure: h
	2.18 (0.459)	1.17 (0.632)

24. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Overall Number of Participants Analyzed	6	7	6	6	7	6
Mean (Standard Deviation); Unit of Measure: ng/mL
	0.104 (0.0555)	0.1 (0.073)	0.384 (0.177)	0.437 (0.419)	0.603 (0.513)	0.587 (0.182)

25. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	Tmax: The time at which Cmax was observed
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed
Overall Number of Participants Analyzed	5	7	6	6	7	6
Mean (Standard Deviation); Unit of Measure: h
	2.86 (1.17)	2.91 (1.11)	1.38 (1.3)	1.86 (1.69)	3.08 (3.42)	1.93 (1.71)

26. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Overall Number of Participants Analyzed	5	7	6	6	7	6
Mean (Standard Deviation); Unit of Measure: ng/mL
	0.0453 (0.0272)	0.0418 (0.0152)	0.0568 (0.0292)	0.0332 (0.0183)	0.204 (0.188)	0.0994 (0.144)

27. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	Tlast: The time at which Clast was observed
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed
Overall Number of Participants Analyzed	5	7	6	6	7	6
Mean (Standard Deviation); Unit of Measure: h
	9.66 (8.25)	8.86 (7.82)	14.4 (7.86)	16.1 (9.05)	12.6 (9.85)	18.4 (8.97)

28. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Overall Number of Participants Analyzed	6	7	6	6	7	6
Mean (Standard Deviation); Unit of Measure: h*ng/mL
	0.459 (0.396)	0.467 (0.473)	1.22 (0.761)	1.27 (0.637)	2.64 (2.52)	2.26 (1.07)

29. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Overall Number of Participants Analyzed	1	1	1	4	2	2
Mean (Standard Deviation); Unit of Measure: h*ng/mL
	1.83 [1] (NA)	1.11 [1] (NA)	0.535 [1] (NA)	1.76 (0.762)	7.58 (5.12)	2.76 (0.399)

[1]

Not determined, or not reported due to insufficient data for reliable estimate

30. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Overall Number of Participants Analyzed	1	1	3	5	4	2
Mean (Standard Deviation); Unit of Measure: h*ng/mL
	1.09 [1] (NA)	1.09 [1] (NA)	1.08 (0.484)	1.45 (0.588)	3.08 (1.32)	2.61 (0.226)

[1]

Not determined, or not reported due to insufficient data for reliable estimate

31. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	t1/2: Terminal half-life, calculated as λn/(ln 2)
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.05 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.05 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.1 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose
Arm/Group Description:	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)
Overall Number of Participants Analyzed	1	1	1	4	2	2
Mean (Standard Deviation); Unit of Measure: h
	20.5 [1] (NA)	4.48 [1] (NA)	2.31 [1] (NA)	8.67 (8.06)	18.7 (22.5)	5.18 (2.55)

[1]

Not determined, or not reported due to insufficient data for reliable estimate

32. Secondary Outcome

Title	Dose-Normalized 6 Beta-Hydroxyoxymorphone CL/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the CL/F.

Arm/Group Title	Combined 0.05, 0.1, and 0.2 mg/kg - Aged 6 Years to ≤ 12 Years	Combined 0.05, 0.1, and 0.2 mg/kg - Aged 2 Years to <6 Years
Arm/Group Description:	CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf	CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf
Overall Number of Participants Analyzed	4	7
Mean (Standard Deviation); Unit of Measure: L/h/kg
	70.7 (78.8)	65 (23.2)

33. Secondary Outcome

Title	Dose-Normalized 6 Beta-Hydroxyoxymorphone V/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase
Description	V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
Time Frame	Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the V/F.

Arm/Group Title	Combined 0.05, 0.1, and 0.2 mg/kg - Aged 6 Years to ≤ 12 Years	Combined 0.05, 0.1, and 0.2 mg/kg - Aged 2 Years to <6 Years
Arm/Group Description:	V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)	V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf * λn)
Overall Number of Participants Analyzed	4	7
Mean (Standard Deviation); Unit of Measure: L/kg
	631 (308)	575 (487)

34. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Cmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Overall Number of Participants Analyzed	10	5	3	0
Mean (Standard Deviation); Unit of Measure: ng/mL
	0.547 (0.472)	0.829 (0.541)	1.41 (0.473)

35. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	Tmax: The time at which Cmax was observed
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed	Tmax: The time at which Cmax was observed
Overall Number of Participants Analyzed	10	5	3	0
Mean (Standard Deviation); Unit of Measure: h
	1.67 (1.01)	1.37 (1.5)	1.36 (0.85)

36. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Clast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval	Clast: Minimum plasma concentration; the last concentration observed during a dosage interval
Overall Number of Participants Analyzed	10	5	3	0
Mean (Standard Deviation); Unit of Measure: ng/mL
	0.201 (0.118)	0.225 (0.139)	1.25 (0.585)

37. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	Tlast: The time at which Clast was observed
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tlast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed	Tlast: The time at which Clast was observed
Overall Number of Participants Analyzed	10	5	3	0
Mean (Standard Deviation); Unit of Measure: h
	3.97 (1.05)	4.47 (1.68)	2.09 (0.077)

38. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of AUC0-t was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule	AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule
Overall Number of Participants Analyzed	10	5	3	0
Mean (Standard Deviation); Unit of Measure: h*ng/mL
	1.35 (1.27)	1.61 (1.19)	2.25 (0.547)

39. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn	AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn
Overall Number of Participants Analyzed	3	3	1	0
Mean (Standard Deviation); Unit of Measure: h*ng/mL
	2.15 (0.769)	1.79 (1.73)	7.66 [1] (NA)

[1]

Not determined, or not reported due to insufficient data for reliable estimate

40. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule	AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule
Overall Number of Participants Analyzed	3	3	1	0
Mean (Standard Deviation); Unit of Measure: h*ng/mL
	2.11 (0.748)	1.78 (1.72)	7.38 [1] (NA)

[1]

Not determined, or not reported due to insufficient data for reliable estimate

41. Secondary Outcome

Title	6 Beta-Hydroxyoxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7
Description	t1/2: Terminal half-life, calculated as λn/(ln 2)
Time Frame	Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Outcome Measure Data

Analysis Population Description

PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Arm/Group Title	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 1	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 1	0.2 mg/kg - Children Aged 6 Years to ≤12 Years - Dose 7	0.2 mg/kg - Children Aged 2 Years to <6 Years - Dose 7
Arm/Group Description:	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)	t1/2: Terminal half-life, calculated as λn/(ln 2)
Overall Number of Participants Analyzed	3	3	1	0
Mean (Standard Deviation); Unit of Measure: h
	3.61 (1.67)	1.42 (0.73)	4.9 [1] (NA)

[1]

Not determined, or not reported due to insufficient data for reliable estimate

Adverse Events

Time Frame	All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study.
Adverse Event Reporting Description	AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Arm/Group Title	6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg		6 Years to ≤ 12 Years Age Group: Single Dose 0.10 mg/kg		6 Years to ≤ 12 Years Age Group: Single Dose 0.20 mg/kg		2 Years to < 6 Years Age Group: Single Dose 0.05 mg/kg		2 Years to < 6 Years Age Group: Single Dose 0.10 mg/kg		2 Years to < 6 Years Age Group: Single Dose 0.20 mg/kg		0 to < 2 Years Age Group: Single Dose 0.05 mg/kg		6 Years to ≤ 12 Years Age Group: Multiple Dose 0.20 mg/kg		2 Years to < 6 Years Age Group: Multiple Dose 0.20 mg/kg
Arm/Group Description	All (serious and nonserious) AEs for the 6 years to ≤ 12 years Age Group - Single Dose 0.05 mg/kg		All (serious and nonserious) AEs for the 6 years to ≤ 12 years Age Group - Single Dose 0.10 mg/kg		All (serious and nonserious) AEs for the 6 years to ≤ 12 years Age Group - Single Dose 0.20 mg/kg		All (serious and nonserious) AEs for the 2 years to < 6 years Age Group - Single Dose 0.05 mg/kg		All (serious and nonserious) AEs for the 2 years to < 6 years Age Group - Single Dose 0.10 mg/kg		All (serious and nonserious) AEs for the 2 years to < 6 years Age Group - Single Dose 0.20 mg/kg		All (serious and nonserious) AEs for the 0 to < 2 years Age Group - Single Dose 0.05 mg/kg		All (serious and nonserious) AEs for the 0 to < 2 years Age Group - Multiple Dose 0.20 mg/kg		All (serious and nonserious) AEs for the 2 to < 6 years Age Group - Multiple Dose 0.20 mg/kg
All-Cause Mortality
	6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg		6 Years to ≤ 12 Years Age Group: Single Dose 0.10 mg/kg		6 Years to ≤ 12 Years Age Group: Single Dose 0.20 mg/kg		2 Years to < 6 Years Age Group: Single Dose 0.05 mg/kg		2 Years to < 6 Years Age Group: Single Dose 0.10 mg/kg		2 Years to < 6 Years Age Group: Single Dose 0.20 mg/kg		0 to < 2 Years Age Group: Single Dose 0.05 mg/kg		6 Years to ≤ 12 Years Age Group: Multiple Dose 0.20 mg/kg		2 Years to < 6 Years Age Group: Multiple Dose 0.20 mg/kg
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/6 (0.00%)		0/6 (0.00%)		0/7 (0.00%)		0/7 (0.00%)		0/6 (0.00%)		0/6 (0.00%)		0/7 (0.00%)		0/10 (0.00%)		0/6 (0.00%)
Serious Adverse Events
	6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg		6 Years to ≤ 12 Years Age Group: Single Dose 0.10 mg/kg		6 Years to ≤ 12 Years Age Group: Single Dose 0.20 mg/kg		2 Years to < 6 Years Age Group: Single Dose 0.05 mg/kg		2 Years to < 6 Years Age Group: Single Dose 0.10 mg/kg		2 Years to < 6 Years Age Group: Single Dose 0.20 mg/kg		0 to < 2 Years Age Group: Single Dose 0.05 mg/kg		6 Years to ≤ 12 Years Age Group: Multiple Dose 0.20 mg/kg		2 Years to < 6 Years Age Group: Multiple Dose 0.20 mg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0.00%)		1/6 (16.67%)		0/7 (0.00%)		1/7 (14.29%)		0/6 (0.00%)		0/6 (0.00%)		0/7 (0.00%)		2/10 (20.00%)		0/6 (0.00%)
Blood and lymphatic system disorders
Neutropenia † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Infections and infestations
Abdominal abscess † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	0/6 (0.00%)	0
Injury, poisoning and procedural complications
Joint dislocation † 1	0/6 (0.00%)	0	1/6 (16.67%)	1	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Postoperative fever † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Wound dehiscence † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	0/6 (0.00%)	0
1 Term from vocabulary, MedDRA (19.0); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg		6 Years to ≤ 12 Years Age Group: Single Dose 0.10 mg/kg		6 Years to ≤ 12 Years Age Group: Single Dose 0.20 mg/kg		2 Years to < 6 Years Age Group: Single Dose 0.05 mg/kg		2 Years to < 6 Years Age Group: Single Dose 0.10 mg/kg		2 Years to < 6 Years Age Group: Single Dose 0.20 mg/kg		0 to < 2 Years Age Group: Single Dose 0.05 mg/kg		6 Years to ≤ 12 Years Age Group: Multiple Dose 0.20 mg/kg		2 Years to < 6 Years Age Group: Multiple Dose 0.20 mg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/6 (83.33%)		4/6 (66.67%)		4/7 (57.14%)		7/7 (100.00%)		5/6 (83.33%)		3/6 (50.00%)		4/7 (57.14%)		10/10 (100.00%)		4/6 (66.67%)
Blood and lymphatic system disorders
Coagulopathy † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	1/6 (16.67%)	1
Cardiac disorders
Bradycardia † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Sinus arrhythmia † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Tachycardia † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Gastrointestinal disorders
Abdominal distension † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	2/7 (28.57%)	2	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Constipation † 1	0/6 (0.00%)	0	1/6 (16.67%)	1	0/7 (0.00%)	0	0/7 (0.00%)	0	2/6 (33.33%)	2	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	0/6 (0.00%)	0
Diarrhoea † 1	0/6 (0.00%)	0	1/6 (16.67%)	1	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	0/6 (0.00%)	0
Nausea † 1	0/6 (0.00%)	0	1/6 (16.67%)	1	1/7 (14.29%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	1/6 (16.67%)	1	0/7 (0.00%)	0	4/10 (40.00%)	4	0/6 (0.00%)	0
Vomiting † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	1/7 (14.29%)	1	0/7 (0.00%)	0	2/6 (33.33%)	2	0/6 (0.00%)	0	1/7 (14.29%)	1	4/10 (40.00%)	5	0/6 (0.00%)	0
Ileus paralytic † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	0/6 (0.00%)	0
General disorders
Face oedema † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Generalised oedema † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Localised oedema † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	1/7 (14.29%)	1	0/10 (0.00%)	0	0/6 (0.00%)	0
Oedema peripheral † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	2/7 (28.57%)	3	0/6 (0.00%)	0	0/6 (0.00%)	0	2/7 (28.57%)	3	0/10 (0.00%)	0	1/6 (16.67%)	1
Peripheral swelling † 1	0/6 (0.00%)	0	1/6 (16.67%)	1	0/7 (0.00%)	0	1/7 (14.29%)	1	1/6 (16.67%)	1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Pyrexia † 1	0/6 (0.00%)	0	3/6 (50.00%)	6	1/7 (14.29%)	1	0/7 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0	0/7 (0.00%)	0	2/10 (20.00%)	2	1/6 (16.67%)	1
Fatigue † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	0/6 (0.00%)	0
Oedema † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	0/6 (0.00%)	0
Injury, poisoning and procedural complications
Fall † 1	1/6 (16.67%)	1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/0	0	0/2 (0.00%)	0
Postoperative fever † 1	1/6 (16.67%)	1	1/6 (16.67%)	1	0/7 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/0	0	0/2 (0.00%)	0
Procedural anxiety † 1	1/6 (16.67%)	1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Procedural pain † 1	1/6 (16.67%)	2	0/6 (0.00%)	0	0/7 (0.00%)	0	2/7 (28.57%)	2	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Procedural vomiting † 1	1/6 (16.67%)	1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Procedural nausea † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	2/7 (28.57%)	2	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Infusion site oedema † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	0/6 (0.00%)	0
Investigations
Alanine aminotransferase increased † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	1/7 (14.29%)	1	0/10 (0.00%)	0	0/6 (0.00%)	0
Aspartate aminotransferase increased † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	1/7 (14.29%)	1	1/10 (10.00%)	1	0/6 (0.00%)	0
Clostridium test positive † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Haematocrit decreased † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	1/7 (14.29%)	1	0/10 (0.00%)	0	0/6 (0.00%)	0
Red blood cell count decreased † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	1/7 (14.29%)	1	0/10 (0.00%)	0	0/6 (0.00%)	0
White blood cell count decreased † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	1/7 (14.29%)	1	0/10 (0.00%)	0	0/6 (0.00%)	0
Haemoglobin decreased † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	1/7 (14.29%)	1	0/10 (0.00%)	0	0/6 (0.00%)	0
Musculoskeletal and connective tissue disorders
Foot deformity † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Muscle spasms † 1	0/6 (0.00%)	0	2/6 (33.33%)	2	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Arthralgia † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	0/6 (0.00%)	0
Nervous system disorders
Cerebrospinal fluid leakage † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Headache † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	2/10 (20.00%)	2	0/6 (0.00%)	0
Lethargy † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	0/6 (0.00%)	0
Sedation † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	0/6 (0.00%)	0
Vision blurred † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	0/6 (0.00%)	0
Somnolence † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	1/6 (16.67%)	1
Product Issues
Device dislocation † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	1/7 (14.29%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Psychiatric disorders
Anxiety † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	1/7 (14.29%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Renal and urinary disorders
Enuresis † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	1/6 (16.67%)	1
Reproductive system and breast disorders
Oedema genital † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Hypoxia † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/6 (16.67%)	1	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Atelectasis † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	0/6 (0.00%)	0
Pleural effusion † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	0/6 (0.00%)	0
Skin and subcutaneous tissue disorders
Pruritus † 1	1/6 (16.67%)	1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	1/6 (16.67%)	1
Blood blister † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Dermatitis contact † 1	0/6 (0.00%)	0	1/6 (16.67%)	1	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Erythema † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Rash † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/6 (16.67%)	1	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Swelling face † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Surgical and medical procedures
Incisional drainage † 1	0/6 (0.00%)	0	1/6 (16.67%)	3	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
Central venous catheterisation † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	1/10 (10.00%)	1	0/6 (0.00%)	0
Vascular disorders
Hypotension † 1	0/6 (0.00%)	0	0/6 (0.00%)	0	1/7 (14.29%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/6 (0.00%)	0	0/7 (0.00%)	0	0/10 (0.00%)	0	0/6 (0.00%)	0
1 Term from vocabulary, MedDRA (19.0); † Indicates events were collected by systematic assessment

Limitations and Caveats

This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Saji Vijayan
• Organization: Endo Pharmaceuticals
• Phone: (800) 462-3636
• EMail: ClinicalTrials@Endo.com

• Responsible Party: Endo Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01210352
• Other Study ID Numbers: EN3319-302
• First Submitted: September 17, 2010
• First Posted: September 28, 2010
• Results First Submitted: December 20, 2018
• Results First Posted: May 7, 2019
• Last Update Posted: August 20, 2021