BioDelivery Sciences International, Inc. (BDSI) announced 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 enrolment 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."

BDSI believes that there remains a significant unmet medical need for potent new analgesics for the treatment of chronic pain.  The company believes that buprenorphine is an attractive option for development because of its potent analgesic properties, its differentiating characteristics from other opioids and its DEA Schedule III designation, which means there is less addiction potential than Schedule II products such as oxycodone and morphine.  In addition, BDSI believes that BEMA Buprenorphine has the potential to be the first oral transmucosal form of buprenorphine to treat chronic pain in the US.  According to Wolters Kluwer, opioid analgesic sales in the US are in excess of $10 billion and growing, and BDSI believes that BEMA Buprenorphine has the potential to exceed $500 million in peak annual sales.

BioDelivery Sciences International is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics.