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

BioDelivery Sciences International

Status and phase

Withdrawn

Phase 3

Conditions

Pain

Low Back Pain

Treatments

Drug: BEMA Buprenorphine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01431742

BUP-306

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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