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BDSI Announces Positive Key Secondary Efficacy Endpoint Results for,Bema Fentanyl

ntanyl through the mucosal membrane and a major need for our target patients."

Dr. Mark Sirgo, President and CEO of BDSI, commented: "These additional efficacy results continue to define the profile of BEMA(TM) Fentanyl in treating breakthrough cancer pain. Based on the combination of what we believe is a convenient and comfortable delivery form with the early pain intensity reduction demonstrated in our study, we remain confident that BEMA(TM) Fentanyl has the potential to play an important role in the future treatment of breakthrough cancer pain. Based on this additional efficacy information, and assuming NDA acceptance and approval by FDA and that our development and commercialization activities will continue as planned, we continue to believe we will ultimately reach our annual peak sales projection of $250 million for the treatment of breakthrough cancer pain."

BDSI recently announced that the New Drug Application (NDA) for BEMA(TM) Fentanyl is scheduled for submission during the third quarter of 2007. Prior to this submission, BDSI will conduct a pre-NDA meeting with the FDA on June 28, 2007 to discuss results of the efficacy trial, along with the safety data and other requirements for the NDA submission.

About the BEMA(TM) Technology

BDSI's BEMA(TM) drug delivery technology consists of a dissolvable, dime-sized polymer disc for application to the mucosal (inner lining of cheek) membrane. BEMA(TM) discs deliver a rapid, reliable dose of drug across mucous membranes for time-critical conditions or trauma cases where intravenous lines or injections are unavailable or not practical.

About BEMA(TM) Fentanyl

BDSI's lead product under development is BEMA(TM) Fentanyl, a treatment for "breakthrough" cancer pain (i.e., episodes of severe pain which "break through" the medication used to control the persistent pain). BDSI believes there is a clear need and growing market for additional narcotic agents in alternative dosage form
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