BDSI announces positive phase III clinical trial results

y efficacy parameters, our plan will be to submit the data to a scientific conference for presentation. We will do that at the first available opportunity and at the most appropriate forum. However, we wanted to be able to share the news that we have achieved the most important endpoint, namely the SPID 30, at this time," concluded Dr. Finn.

Dr. Mark Sirgo, President and CEO of BDSI, commented, "These Phase III results demonstrate that the BEMA delivery system is effective in delivering a significant level of fentanyl over a range of doses to manage the breakthrough cancer pain that occurred in these patients. The results also demonstrated that the dosage form was convenient and comfortable to use. Importantly, we believe that the dose linearity (i.e. double the dose and double the plasma concentration of the drug) demonstrated in our previously announced pharmacokinetic studies up to the 1200 mcg dose provide the ability to relieve breakthrough cancer pain in a higher percentage of patients. This was demonstrated by the fact that only 3% of patients who entered the titration phase did not proceed to the double blind, placebo controlled phase of the study because they could not achieve adequate pain control. Overall, given the efficacy profile of BEMA Fentanyl as demonstrated during this Phase III study, along with the apparent ease of use and comfort of the BEMA disc, we remain confident that BEMA Fentanyl has the potential to play an important role in the future treatment of breakthrough cancer pain."

In 2006, franchise sales for the market leader in rapid acting fentanyl products were a reported $659 million, while only treating less than 50,000 of the estimated 500,000 cancer patients with breakthrough pain. "We believe that the efficacy and safety profile of BEMA Fentanyl is well suited to penetrate the 90% of the market that is not served by existing products" commented Dr. Sirgo. "Based on this, and assuming NDA acceptance and appr

Contact: Bill Douglass
BioDelivery Sciences

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