Conditions: Pain Low Back Pain Osteoarthritis Neuropathic Pain
Keywords: buccal soluble film
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 302
Healthy volunteers: no

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

Detailed description:
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.

Arms:
arm 1: buprenorphine buccal soluble film

Interventions: intervention 1: BEMA Buprenorphine
Intervention descriptions: intervention 1: buccal soluble film; applied to the buccal mucosa twice daily

Protocol document: