Raleigh-based BioDelivery Sciences has received a complete response letter from the U.S. Food and Drug Administration regarding its application for BEMA Fentanyl.
The firm said the FDA reviewers only called for some changes in risk management documents. BioDelivery said there were no deficiencies noted in other areas, clearing the way for FDA market approval by the middle of next year. That would also make possible more benchmark payment from Meda AB, a Swedish pharmaceutical company that paid BioDelivery $30 million for U.S., Canadian and Mexican commercialization rights to the drug.
Under the marketing agreement, Meda is responsible for the marketing and distribution of BEMA Fentanyl as well as for managing its clinical development program after the NDA approval.
BEMA Fentanyl, with the trade name ONSOLIS, is an opioid pain reliever taken via the company's "BEMA" system, which involves a drug-impregnated film dissolved on the inside of the cheek. The Fentanyl application is for cancer patients suffering from breakthrough pain -- meaning episodes of severe pain that "break through" the effects of other medications being used to control persistent pain.