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Bema Fentanyl Demonstrates Substantial Transmucosal Delivery In,Absolute Bioavailability Study

ated that fentanyl absorption from the BEMA(TM) delivery system was better than that seen with Actiq(R). This study showed that the absolute bioavailability from BEMA(TM) Fentanyl and the amount of fentanyl absorbed directly through the buccal mucosa were substantial (70% and 50%, respectively). Although the study announced today was not a direct comparative study, our absolute and buccal bioavailability results are greater than those previously reported with Actiq(R) (47% and 22%), and similar to those previously reported with Fentora(TM) (65% and 48%) in separate studies. Given the linear increase in plasma concentrations with increases in dose, and the nearly identical plasma concentrations when a dose is administered as a single disc or as multiple discs, we believe doctors will have the needed flexibility in titrating the dose of BEMA(TM) Fentanyl to meet the changing analgesic requirements of patients with breakthrough cancer pain."

Actiq(R), marketed by Cephalon, Inc., is the leading fentanyl product for the treatment of breakthrough cancer pain in the U.S. market. Cephalon introduced a second fast dissolving fentanyl product, Fentora(TM), in 2006. The reported combined sales of these products in 2006 were $659 million.

Dr. Mark Sirgo, President and CEO of BDSI, stated "These results continue to demonstrate the consistency in the performance of the BEMA(TM) delivery system. The primary objective of a transmucosal delivery system is to have a substantial amount of the drug absorbed through that membrane, thereby allowing for a rapid onset of action while minimizing the amount of drug that is swallowed. Today's results show that the BEMA(TM) technology and our BEMA(TM) Fentanyl product specifically meet this objective. These results, when combined with the recent announcement of achieving our primary efficacy endpoint in our breakthrough cancer pain Phase III efficacy study, give us continued confidence that the commercial value for BEMA(TM) Fenta
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