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BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of Second Quarter 2014 Financials
Date:8/7/2014

RALEIGH, N.C., Aug. 7, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended June 30, 2014 with the U.S. Securities and Exchange Commission and, in connection therewith, is providing a review of BDSI's recent achievements and an update on business operations and upcoming milestones for 2014.

In June, BDSI received approval of the New Drug Application (NDA) for BUNAVAIL™ (buprenorphine and naloxone) buccal film from the U.S. Food and Drug Administration (FDA). BUNAVAIL is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. BUNAVAIL is the first and only FDA-approved buccal film formulation of buprenorphine and naloxone and will compete in the $1.7 billion and growing U.S. opioid dependence market. BDSI expects to launch BUNAVAIL late in the third quarter of 2014 with a dedicated U.S. sales force.  BDSI plans to share additional details on its launch plans at its Investor and Analyst Luncheon on September 5, 2014 in New York City.

On July 7, Endo Pharmaceuticals and BDSI announced positive top-line results from its second pivotal Phase 3 efficacy study of BEMA Buprenorphine in opioid-experienced patients. The trial successfully met its primary efficacy endpoint in demonstrating that BEMA Buprenorphine resulted in significantly improved chronic pain relief compared to placebo. Additional secondary endpoints were supportive of the efficacy of BEMA Buprenorphine compared to placebo. The locking of the database for the opioid-experienced study also triggered a $10 million milestone payable from Endo to BDSI.  Endo and BDSI plan to submit an NDA to FDA by year-end or early 2015.  <
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SOURCE BioDelivery Sciences International, Inc.
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