Morrisville pharmaceutical company BioDelivery Sciences International (BDSI) announced it has submitted a New Drug Application to the U.S. Food and Drug Administration for its BEMA Fentanyl treatment for "breakthrough" cancer pain.
BDSI's BEMA Fentanyl uses a polymer wafer formulated with the opioid narcotic fentanyl. It's designed to be safely dissolved against the inner lining of the cheek.
BDSI recently announced a U.S. commercialization partnership on the therapy with Swedish specialty pharmaceutical company Meda AB. BDSI expects a final decision from the FDA on or before August. If the product is approved for clinical use, BDSI is expected to receive milestone payments from Meda totaling $30 million and could begin receiving royalty revenues from the product as early as fourth quarter of 2008.
BDSI, which has a manufacturing plant in New Jersey, has projected that BEMA Fentanyl could bring annual revenue of at least $250 million in the U.S. alone.