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

tical significance (p=0.066).  This starting dose "phenomenon" is not dissimilar to what has been observed with other approved opioids."

Dr. Finn concluded, "We observed significant efficacy in the opioid experienced subset of patients and believe there is a clear pathway forward to determine the same in the opioid naive patients.  We are also pleased to see that the product was well tolerated and that no unexpected side effects were seen.  Our overall evaluation of the data in these two patient populations has given us valuable insight and confidence that we will use in commencing a new study."  

"While there is disappointment over missing the primary efficacy endpoint of this study, the many positive findings we observed gives us great confidence in our ability to ultimately bring this product to market for the treatment of chronic pain in a variety of patient types," stated Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  

"Opioid naive and opioid experienced patients make up nearly 75% of all people requiring treatment for pain.  Our strategy was to capture both populations in our product label through the conduct of one trial rather than performing separate studies" continued Dr. Sirgo.  "We had an unusually high placebo response in the naive group of patients while the experienced group of patients responded as we had anticipated.  With some tightening of the study entry criteria and a few design adjustments, we are confident we can complete a successful trial."  

"In short, we know buprenorphine works in treating pain.  This opportunity has never been an "if" but a "when", and this study affirms our belief in this regard," continued Dr. Sirgo.  "We continue to believe that BEMA Buprenorphine has the opportunity to be the first transmucosal product for the treatment of chronic pain to reach the marketplace.  Our previously announced market projections for
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SOURCE BioDelivery Sciences International, Inc.
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