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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
buccal soluble film; applied to the buccal mucosa twice daily
Unnamed facility
Marietta, Georgia, United States
Mean change in pain intensity
The average of the visit pain scores for Baseline up to approximately Week 52
Time frame: Baseline up to approximately Week 52
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