Long-term Open-Label Safety Study to Evaluate EN3409

This study has been completed.
BioDelivery Sciences International
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
First received: December 19, 2012
Last updated: June 10, 2015
Last verified: June 2015
The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.

Condition Intervention Phase
Low Back Pain
Neuropathic Pain
Drug: EN3409
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Open-label, Long-term Study to Evaluate the Safety, Tolerability, and Analgesic Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain Requiring Continuous Around-the-Clock Opioid Analgesia for an Extended Period of Time

Resource links provided by NLM:

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • To determine the long-term safety and tolerability of BEMA Buprenorphine (dosed every 12 hours [Q12h]) in subjects with moderate to severe chronic pain (CP) requiring continuous around-the-clock (ATC) opioid analgesia for an extended period of time [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 554
Study Start Date: December 2012
Study Completion Date: November 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EN3409
Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily
Drug: EN3409
Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily
Other Name: Buprenorphine HCI Buccal Film 300-900 mcg twice daily


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female subjects who are practicing abstinence or using a medically acceptable form of contraception or have been postmenopausal, biologically sterile, or surgically sterile for more than 1 year
  • Male subjects who are practicing abstinence, surgically sterile, or are using a medically acceptable form of contraception
  • De Novo subject with a clinical diagnosis of moderate to severe noncancer-related CP (eg, CLBP, OA, neuropathic pain) for ≥ 3 months
  • De Novo subject that is treating their CP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥ 60 mg and ≤ 160 mg Morphine Sulfate Equivalent (MSE) per day for ≥ 4 weeks
  • Stable health, as determined by the Principal Investigator
  • Subject is willing and able to comply with all protocol required visits and assessments
  • Rollover subject who has completed the 12-week Double-blind Treatment Phase in the EN3409-307/308 clinical study

Exclusion Criteria:

  • A history or current evidence of any clinically significant disorder or any other condition, which in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
  • Females who are pregnant, breastfeeding, or plan to become pregnant during the study
  • Current cancer-related pain or received chemotherapy within 6 months of screening
  • Subjects receiving opioid analgesic medication < 60 mg MSE per day within 28 days of screening
  • De novo subjects receiving opioid analgesic medication at doses of > 160 mg MSE per day within 28 days of screening
  • Subjects with a history of other chronic painful conditions, other than the index CP condition, which require frequent analgesic medication
  • Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
  • History of allergy or contraindications to any opioid or acetaminophen
  • Surgical procedure for relief of pain within 6 months, or nerve/plexus block within 28 days of screening
  • Hypokalemia or clinically unstable cardiac disease
  • Moderate to severe hepatic impairment
  • Moderate to severe renal impairment
  • Current or past history of alcohol or substance
  • Positive urine toxicology screen for drugs of abuse
  • History of abnormalities on physical exam, vital signs, ECG, or lab values
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755546

  Show 57 Study Locations
Sponsors and Collaborators
Endo Pharmaceuticals
BioDelivery Sciences International
Study Director: Andrew Finn, PharmD BioDelivary Sciences Internantional, Inc.
  More Information

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01755546     History of Changes
Other Study ID Numbers: EN3409-309 
Study First Received: December 19, 2012
Last Updated: June 10, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
Chronic Pain
Chronic Low Back Pain
Back Pain
Neuropathic Pain
Nerve pain
Painful neuropathy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Peripheral Nervous System Diseases
Rheumatic Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016