BEMA Buprenorphine submitted to FDA for Pain-Endo Pharma/BioDelivery Sci

Endo Pharmaceuticals and BioDelivery Sciences International have submitted a New Drug Application (NDA) for BEMA Buprenorphine HCl Buccal Film (buprenorphine/naloxone) to the FDA for the management of Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The drug uses BDSI's patented BioErodible MucoAdhesive (BEMA) drug delivery technology to efficiently and conveniently deliver buprenorphine across the buccal mucosa. Submission was based on two pivotal Phase III studies for demonstration of safety and efficacy. These double-blind randomized, placebo-controlled, enriched-enrollment studies were in patients with chronic lower back pain.

One study (BUP-307) was conducted in opioid experienced subjects, and the second study (BUP-308) was conducted in subjects na�ve to opioid therapy. Both studies met the primary efficacy endpoint of change from baseline to week 12 of mean daily pain intensity score from placebo. Buprenorphine HCl Buccal Film was generally well tolerated demonstrating a low incidence of typical opioid like side effects.