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.