BDSI to initiate BEMA Buprenorphine Phase 3 program following positive End-of-Phase 2 meeting with FDA

Oct 28 2010

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today announced a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) which took place on September 14, 2010. At that meeting, agreement was reached on the BEMA Buprenorphine development plan for the treatment of chronic pain. As a result, the Phase 3 clinical program evaluating the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain will be initiated this quarter.

"We are very pleased with the outcome of our End-of-Phase 2 meeting with FDA where clear guidance was provided on our development requirements for BEMA Buprenorphine," stated Dr. David Wright, Vice President of Regulatory Affairs at BDSI. "There were no surprises, and we are moving forward into Phase 3."

According to Dr. Andrew Finn, Executive Vice President of Product Development at BDSI, "Given our clinical and regulatory success with the execution of the ONSOLIS program, we are confident in our ability to efficiently execute this program as planned. Driven by patient enrollment and retention, results could be expected as early as the third quarter of 2011, allowing for a potential NDA filing in the first half of 2012. We hope to be the first oral transmucosal form of buprenorphine for the treatment of pain to be approved for use in the U.S."

Per its existing policy, BDSI deferred a public announcement of this meeting pending its receipt and review of the official minutes from the FDA meeting, which typically takes approximately 30 days to receive.