BioDelivery Sciences is developing BEMA Buprenorphine/Naloxone for the treatment of opioid dependence. The product will combine a "high dose" of buprenorphine along with an abuse deterrent agent, naloxone. Preliminary pharmacokinetic studies have demonstrated the ability of the BEMA technology to deliver the high doses of buprenorphine necessary for the treatment of opioid dependence.

A BEMA Buprenorphine/Naloxone product would provide BDSI with an opportunity to compete in a rapidly growing opioid dependence market. Buprenorphine is widely used in the treatment of opioid dependence and is marketed as Suboxone® (buprenorphine/naloxone) and Subutex® (buprenorphine). Accordingly to Wolters Kluwer, U.S. sales of buprenorphine containing products for the treatment of opioid dependence exceeded $1 billion in 2010. Initial pharmacokinetic studies have demonstrated the ability of the BEMA technology to deliver doses of buprenorphine needed for the treatment of opioid dependence.

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced positive preliminary results from its Phase 1 study assessing the pharmacokinetics of a BEMA Buprenorphine/Naloxone formulation. BDSI is seeking to develop and commercialize a high dose formulation of buprenorphine combined with naloxone (abuse deterrent agent) for the treatment of opioid dependence.

This study assessed buprenorphine and naloxone absorption profiles from BDSI’s BioErodible MucoAdhesive (BEMA) formulation of buprenorphine/naloxone versus the FDA approved and currently marketed opioid dependence product, Suboxone. Results of the study demonstrated the ability of the BEMA formulation to meet the key pharmacokinetic goal of delivering plasma concentrations of buprenorphine in the range needed to treat opioid dependence while minimizing the exposure of naloxone.

"We are pleased with the results of this study as they are consistent with our expectations and allow us to now optimize our BEMA Buprenorphine/Naloxone formulation prior to conducting the pivotal bioequivalence study," stated Dr. Andrew Finn, Executive Vice President of Product Development at BDSI. "We expect to initiate the pivotal bioequivalence trial in December of this year with results expected during the first quarter of 2012. If the results from this pivotal study are positive, we could be in a position to submit a New Drug Application (NDA) for BEMA Buprenorphine/Naloxone in the second half of 2012."