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BioDelivery Sciences Confirms 505(b)(2) Pathway for BEMA Buprenorphine/Naloxone for Opioid Dependence Following FDA Meeting
Date:3/2/2011

RALEIGH, N.C., March 2, 2011 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced the positive outcome of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) on the development program for BEMA Buprenorphine/Naloxone, BDSI's potential treatment for opioid dependence.  The development program discussed is based on pharmacokinetic and safety data for a 505(b)(2) New Drug Application (NDA).  

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"We believe that the BEMA drug delivery technology is a very efficient and convenient means to deliver buprenorphine for the treatment of opioid dependence," said Dr. Andrew Finn, Executive Vice President of Product Development for BDSI.  "As anticipated, the 505(b)(2) regulatory approach will allow us to more quickly progress the NDA program for BEMA Buprenorphine/Naloxone forward."

BEMA Buprenorphine/Naloxone will utilize BDSI's patented BioErodible MucoAdhesive (BEMA) drug delivery technology to deliver buprenorphine and the abuse deterrent naloxone, which is currently marketed in sublingual formulations known as Suboxone from Reckitt Benckiser.  According to Wolters Kluwer, sales of buprenorphine products for the treatment of opioid dependence exceeded $1 billion in 2010.  BDSI believes that BEMA Buprenorphine/Naloxone has the potential to efficiently deliver buprenorphine and will provide patients with an easy to use thin film formulation that adheres to the inner cheek and quickly dissolves.

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 de
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SOURCE BioDelivery Sciences International, Inc.
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