BEMA Buprenorphine meets endpoints in Pain trial-Endo Pharma

Endo Pharmaceuticals and BioDelivery Sciences International have announced positive top-line results from a pivotal Phase III efficacy study of BEMA Buprenorphine (buprenorphine/naloxone), for treating Pain in opioid-"naive" subjects. The trial successfully met its primary efficacy endpoint in demonstrating that BEMA buprenorphine resulted in significantly 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 III 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.