BioDelivery Sciences International, Inc. (BDSI) announced positive preliminary results from its phase I 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.”

BEMA Buprenorphine/Naloxone is the first BEMA formulation to include two drugs – high dose buprenorphine which reduces the craving and withdrawal effects from the dependent opioid, and an opioid antagonist, naloxone, to deter abuse.

Opioid dependence is a significant healthcare concern in the US with nearly 2 million people dependent on prescription opioids. Suboxone is the most widely prescribed treatment for opioid dependence, with annual sales exceeding $1 billion in the US and continuing to grow steadily according to data from Wolters Kluwer. BDSI believes that the BEMA delivery technology may offer a convenient alternative to Suboxone for the treatment of opioid dependence.

BioDelivery Sciences International (BDSI) 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.