FDA accepts BioDelivery Sciences' application for cancer pain drug

RALEIGH, N.C. The Food and Drug Administration has accepted BioDelivery Sciences International’s application for the drug BEMA Fentanyl, for the management of breakthrough cancer pain in opioid tolerant patients.

BEMA Fentanyl is a small, dissolvable, polymer disc, that applies to the inner lining of the cheek. If approved, BioDelivery is expected to receive milestone payments from its commercial partner, Meda AB, totaling $30 million. In September 2007, BDSI announced a licensing agreement with Meda AB for the distribution rights in the U.S., Canada and Mexico for BEMA Fentanyl.

The application was submitted on Oct. 31, 2007 and a final decision is expected by the FDA in August 2008. The Fentanyl market is expected to exceed $1.5 billion over the next several years.