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BioDelivery Sciences Initiates Confirmatory Pharmacokinetic Study of BEMA Buprenorphine/Naloxone Compared to Suboxone
Date:11/10/2011

begin in January 2012 with results expected in March.

"We have taken an approach we believe provides the highest chance for optimizing this formulation," said Dr. Andrew Finn, Executive Vice President of Product Development at BDSI.  "This confirmatory pharmacokinetic study will provide us with data in December that will be instrumental in helping to ensure that the best possible formulation and doses are used in the pivotal bioequivalence study."

"We believe we are on course to become one of the first products to compete with Suboxone, a product with sales in excess of a billion dollars annually and currently without competition," stated Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  "We believe our BEMA delivery technology can address the challenges that have been encountered by other potential competitors to Suboxone up to this point.  The results from this study should confirm that we are on target to meet this goal."

A positive outcome of BNX-103 will show that BEMA Buprenorphine/Naloxone is bioequivalent to Suboxone, and at that point, an open-label safety study in opioid dependent patients will be conducted.  How quickly full enrollment in this safety study is achieved, as well as study results, will dictate the timing of an NDA submission, which is currently targeted for late 2012 or early 2013.

About BioDelivery Sciences International

BioDelivery Sciences International (NASDAQ: 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.  BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care.  BDSI's pain franchise currentl
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SOURCE BioDelivery Sciences International, Inc.
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