BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today that the last patient has completed the randomized portion of its Phase 3 clinical trial assessing the efficacy
and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain, signifying completion of the trial.
"We are very pleased to have brought to completion our Phase 3 efficacy study for BEMA Buprenorphine in the management of chronic pain," stated Dr. Andrew Finn, Executive Vice President of Product Development at BDSI. "We have achieved our aggressive recruitment and enrollment goals and anticipate reporting top line results in mid to late September of this year. Over the next several weeks, we will be completing the administrative activities that will lead to a database lock followed by statistical analysis and the availability of top line results. Assuming positive study results, we would hope to be in a position to file a New Drug Application (NDA) for this product in the first half of 2012."
BioDelivery Sciences International, Inc.