Date:4/5/2011

an "enriched" enrollment, double-blind, placebo-controlled, randomized withdrawal study measuring the efficacy and safety of BEMA Buprenorphine in patients with moderate to severe chronic pain.  Patients meeting the designated study criteria undergo titration with BEMA Buprenorphine to a dose that is both effective and well-tolerated.  Those patients who identify an effective and well tolerated dose are then randomized to either continue their BEMA Buprenorphine dose or begin use of a placebo (BEMA film with no active drug) for twelve weeks.  The primary efficacy measure is the mean change in pain intensity from the time patients are randomized (to BEMA Buprenorphine or placebo) through to the end of the twelve week study period.  The study design described has been utilized for a number of the opioid analgesics approved by the FDA in recent years.  The study design includes an interim analysis to confirm the number of patients needed for adequate statistical power.  This interim analysis is part of the study design agreed upon with FDA and is included solely to provide assurance that the sample size is adequate to detect the effect difference between the active and placebo treatments. 

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 develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics.  BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care.  BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology.  ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada,
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SOURCE BioDelivery Sciences International, Inc. Copyright©2010 PR Newswire. All rights reserved

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