BDSI TO RESTART TRIALS OF FENTANYL PRODUCT IN CALIFORNIA

BioDelivery Sciences International (BSDI) announced that the Research Advisory Panel of California has approved BDSI's two Phase III protocols for its flagship BEMATM Fentanyl product.

This approval allows BDSI to continue recruitment at existing investigational sites and to initiate new sites for these two protocols in the state of California. The panel had mandated a temporary cessation of recruitment at investigational sites in California in August pending its review of the informed consent document being used for the program. BEMATM Fentanyl is being targeted for the treatment of breakthrough cancer pain.

"The re-initiation of our program in California will begin immediately, and we look forward to including the study results from subjects in California in our anticipated [new drug application] submission on BEMATM Fentanyl," said Mark Sirgo, president and CEO of BDSI. The company recently announced that it intends to submit its application to the FDA during the second quarter of 2007.