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BioDelivery Sciences Announces Completion of Recruitment in BEMA Buprenorphine Phase 3 Chronic Pain Study
Date:4/5/2011

RALEIGH, N.C., April 5, 2011 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today completion of enrollment in its Phase 3 clinical trial assessing the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain.

(Logo: https://photos.prnewswire.com/prnh/20110217/CL49801LOGO)

"The completion of enrollment in our Phase 3 efficacy study marks another very important milestone in our clinical development program for BEMA Buprenorphine in the management of chronic pain," stated Dr. Andrew Finn, Executive Vice President of Product Development at BDSI.  "We are very pleased to have achieved our aggressive recruitment and enrollment goals.  This milestone keeps us on target for reporting top-line study results in the third quarter of this year and is consistent with a timeline that would allow for a New Drug Application (NDA) to be filed in the second quarter of 2012."

BDSI believes that there remains a significant unmet medical need for potent new analgesics for the treatment of chronic pain.  The company believes that buprenorphine is an attractive option for development because of its potent analgesic properties, its differentiating characteristics from other opioids and its DEA Schedule III designation, which means there is less addiction potential than Schedule II products.  In addition, BEMA Buprenorphine has the potential to be the first oral transmucosal form of buprenorphine to treat chronic pain in the U.S.  According to Wolters Kluwer, opioid analgesic sales in the U.S. are in excess of $10 billion and growing, and BDSI believes that BEMA Buprenorphine has the potential to exceed $500 million in peak annual sales.

Additional Information on Phase 3 Study Design (BUP-301)

This Phase 3 trial of BEMA Buprenorphine (referred to as BUP-301) is
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SOURCE BioDelivery Sciences International, Inc.
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