Endo, BioDelivery Post Positive Results In Phase III Trial Of BEMA Buprenorphine

(RTTNews) - Specialty healthcare company Endo International plc's (ENDP, ENL.TO) unit, Endo Pharmaceuticals Inc., and BioDelivery Sciences International, Inc. (BDSI) announced positive top-line results from its pivotal Phase III efficacy study of BEMA buprenorphine in opioid-experienced patients. BEMA buprenorphine is being developed 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 in both patients who are opioid naive and opioid experienced.

The study achieved its primary efficacy endpoint showing that BEMA buprenorphine led to 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 and vomiting.

The Phase III trial was an enriched-enrollment, double-blind, randomized withdrawal study to assess the efficacy and safety of BEMA buprenorphine in the treatment of chronic lower back pain in opioid-experienced patients. A total of 511 patients who titrated to a well-tolerated, effective dose were randomized to either continue on that dose of BEMA buprenorphine, or receive placebo (BEMA film with no active drug), with treatment continuing for 12 weeks.