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BioDelivery Sciences Announces Results from Phase 3 Efficacy Study for BEMA Buprenorphine in Chronic Pain
Date:9/28/2011

the product of $500 million in annual peak sales should not change based on the delay this outcome creates, and we will continue our ongoing partnering discussions in earnest, including the sharing of these results, which we believe should be viewed positively.  We anticipate our partner discussions will also aid us in refining the design for our next study.  In summary, we firmly believe that the future of BEMA Buprenorphine for chronic pain, and for our company in general remains bright."

"Moreover, our stockholders should not lose sight of our equally exciting BEMA Buprenorphine/Naloxone product for the treatment of opioid dependence.  We plan to initiate our pivotal bioequivalence trial by the end of this year with data expected in the first quarter of 2012.  It is important to remember that BDSI growth potential is not dependent on one product and that we will continue to develop our promising product opportunities," concluded Dr. Sirgo.

About the Phase 3 BEMA Buprenorphine Trial

The Phase 3 clinical trial (BUP-301) was an enriched-enrollment, double-blind, randomized withdrawal study to evaluate the efficacy and safety of BEMA Buprenorphine in the treatment of chronic lower back pain in opioid naive and experienced patients.  A total of 334 patients enrolled in the trial.  Patients who titrated to an effective and tolerated dose were randomized to either continue on that dose of BEMA Buprenorphine, or be randomized to placebo (BEMA film with no active drug), with treatment continuing for 12 weeks.  The primary efficacy endpoint was the difference in pain intensity scores (on a numerical rating scale of 0 to 11) from the time patients were randomized to receive either BEMA Buprenorphine or placebo to week twelve.

Conference Call Information

BioDelivery Sciences will hold a webcast on Thursday, September 29, at 8:30 AM Eastern Time to discuss the results of this study.  In
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SOURCE BioDelivery Sciences International, Inc.
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