Positive Results Announced for BioDelivery Sciences’ (BDSI) Pharmacokinetic Study Comparing BEMA Buprenorphine/Naloxone (BNX) to Suboxone

BioDelivery Sciences International announced a positive outcome for the company’s pharmacokinetic study of BEMA Buprenorphine/Naloxone (BNX). BNX is being developed for the potential treatment of opioid dependence and utilizes the company’s patented BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine combined with naloxone, an opioid antagonist. Based on the study’s positive outcome, BioDelivery Sciences continues anticipating that it will be in a position to submit a New Drug Application (NDA) for BNX to the U.S. Food and Drug Administration in the second quarter of 2013.

The study, called BNX-103, was designed to compare the relative bioavailability of buprenorphine and naloxone between BNX and Suboxone, the reference product, which is currently approved for maintenance treatment of opioid dependence. Based upon the FDA’s agreed-upon 505(b)(2) pharmacokinetic regulatory pathway for the BNX program, the focuses of the study were aimed at demonstrating that two key pharmacokinetic parameters – maximum drug plasma concentration (Cmax) and total drug exposure (area under the curve or AUC) – for buprenorphine were comparable to Suboxone, and the same parameters for naloxone were similar to or less than Suboxone. Those goals were achieved.

Based on its prior discussions with the FDA, the company believes that the outcome data of the study supports a key component for its NDA. The study’s positive results demonstrate the importance and versatility of BioDelivery Sciences’ BEMA drug delivery technology and its ability to deliver drugs effectively and efficiently for the treatment of important medical conditions. The study results allow the company to move forward toward the potential filing of an NDA for BNX in 2013, as well as to advance commercialization considerations that include furthering active partnership discussions for BNX.

Going forward, BioDelivery Sciences will continue evaluating its strategic options for commercializing BNX within and outside of the United States, including internal approaches, partnership, or a combination of both. BNX is a substantial asset to the company, and BioDelivery Sciences believes that BNX will, if approved, provide a fairly near-term opportunity to enter and capture a significant share of the more than $1.2 billion burgeoning market for buprenorphine/naloxone by being the first film to compete directly with Suboxone.

BioDelivery Sciences International is a specialty pharmaceutical company engaged in leveraging its novel and proprietary patented drug delivery BEMA technology for the development and commercialization of new applications of proven therapeutics, either independently or in third-party partnerships. The company’s focus is on developing products that meet unmet patient needs in the areas of pain management and addiction. The company’s pain franchise presently consists of two products that utilize the patented BEMA technology: ONSOLIS (fentanyl buccal soluble film), approved in the United States, Canada, and the European Union (where it will be marketed as BREAKYL), which is intended for the management of breakthrough pain in opioid tolerant adult patients with cancer; and BEMA Buprenorphine, which is being developed to treat moderate to severe chronic pain, with a high dose BEMA formulation of buprenorphine and naloxone being developed for the treatment of opioid dependence.

For more information, visit the company’s Web site at www.bdsi.com

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