Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Low Back Pain

Study Overview
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Brief Summary
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This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic low back pain. BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial μ-receptor agonist and a Schedule III controlled substance in the United States.

Official Title
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An Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Low Back Pain

Conditions
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Pain, Low Back Pain

Intervention / Treatment
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* Drug: BEMA Buprenorphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant and non-nursing female aged 18 or older History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 [11 point NRS] reported during screening following discontinuation of current pain medication (opioids and NSAIDs) AND currently taking ≥10 mg oral morphine equivalent/day for ≥2 weeks Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and laboratory results so as to comply with all study procedures Female subjects of childbearing potential must be using a recognized effective method of birth control Written informed consent obtained prior to any procedure being performed Exclusion Criteria: Cancer related pain Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis Surgical procedure for pain within 2 months, or nerve/plexus block within 4 weeks, prior to titration period Day 0/1 visit History of severe emesis with opioids Clinically significant sleep apnea in the judgment of the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BEMA Buprenorphine<br>buprenorphine buccal soluble film | Drug: BEMA Buprenorphine<br>* buccal soluble film; applied to the buccal mucosa twice daily<br>* Other names: buprenorphine buccal soluble film;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in pain intensity | The average of the visit pain scores for Baseline up to approximately Week 52 | Baseline up to approximately Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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buccal soluble film, Pain, Back Pain, Low Back Pain, Buprenorphine, Analgesics, Opioid, Analgesics