Endo Pharmaceuticals Inc. and BioDelivery Sciences International, Inc. announced positive top-line results from its pivotal Phase 3 efficacy study of BEMA buprenorphine in opioid- 'naive' subjects. BEMA buprenorphine is being developed for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy for an extended period of time in both patients who are opioid naive and opioid experienced. The trial successfully met its primary efficacy endpoint in demonstrating that BEMA buprenorphine resulted in significantly (p<0.005) improved chronic pain relief compared to placebo.

Additional secondary endpoints were supportive of the efficacy of BEMA buprenorphine compared to placebo. The most commonly reported adverse events in patients treated with buprenorphine compared to placebo were nausea (10% vs. 8%), vomiting (4% vs.

2%) and constipation (4% vs. 2%). The second Phase 3 clinical study of BEMA Buprenorphine in an opioid "experienced" patient group is ongoing.

Based on recruitment rates in this study, the database for this trial is anticipated to be locked by mid-2014, with results to follow shortly thereafter.