Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain

A 52-Week, Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain

The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.

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 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.

Inclusion Criteria:

• Male or non-pregnant and non-nursing female aged 18 or older

• History of moderate to severe chronic pain:

  1. Subjects completing study BUP-301 (low back pain) or
  2. Osteoarthritis or neuropathic pain, or subjects not completing study BUP-301 (low back pain), pain for ≥3 months with a pain intensity ≥5 [11 point NRS] reported at the titration period Day 0/1 visit following a washout period (opioids, NSAIDs, and muscle relaxants) of approximately 12 to 24 hours AND currently taking ≤60 mg oral morphine equivalent/day (including opioid-naïve) for 1 week or longer

• 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