BEMA Buprenorphine: Phase III data
Top-line data from the double-blind, U.S. Phase III BUP-308 trial in 462 opioid-naïve patients with chronic lower back pain showed that twice-daily BEMA Buprenorphine met the primary endpoint of improving mean daily average pain intensity scores as measured by an 11-point NRS from baseline to week 12 vs. placebo (p<0.005). The most common adverse events reported were nausea, vomiting and constipation. Patients who titrated to a well-tolerated and effective dose of BEMA Buprenorphine in a titration period were randomized to either continue their current dose of BEMA Buprenorphine or placebo in the 12-week, double-blind treatment period. BioDelivery also said the database lock of BUP-308 triggered a $10 million milestone payment from partner Endo to BioDelivery. ...