BEMA Buprenorphine meets in Phase III pain trial

BioDelivery Sciences International Inc. (NASDAQ:BDSI) and partner Endo Health Solutions Inc. (NASDAQ:ENDP) reported that twice-daily BEMA Buprenorphine met the primary endpoint in the Phase III BUP-308 trial to treat moderate to severe chronic pain. BEMA Buprenorphine improved mean daily average pain intensity scores from baseline to week 12 vs. placebo (p<0.005). The double-blind, U.S. trial enrolled 462 opioid-naïve patients with chronic lower back pain. BEMA Buprenorphine is buprenorphine formulated with the BEMA transmucosal delivery system.

The partners plan to submit an NDA to FDA by year end. BioDelivery said the NDA will include treatment of moderate to severe chronic pain in both opioid-naïve and opioid-experienced patients. The partners are developing BEMA Buprenorphine under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. ...