Raleigh-based BioDelivery Sciences said it has been told by the U.S. Food and Drug Administration that the firm must still supply some revised information to get final marketing approval for its experimental lead product, BEMA Fentanyl, a mouth patch designed to ease severe pain in cancer patients.
The FDA accepted BioDelivery's New Drug Application for BEMA Fentanyl in January and company spokesmen said they anticipate final marketing approval sometime during the first half of 2009 -- an event that would trigger a much-anticipated $30 million cash influx. They said it will be marketed in the United States under the trade name ONSOLIS.
The most recent communication from the FDA requested conversion of one portion of and NDA paperwork, called the Risk Minimization Action Plan, into a Risk Evaluation and Mitigation Strategy (REMS). REMS is a new term for a strategy and plan aimed at ensuring the benefits of a drug outweigh its risks, BioDelivery said.
"We are pleased with this significant and extremely positive development for our company," said BioDelivery president and CEO Mark Sirgo, M.D. "We have been anticipating the REMS request and have been proactively evaluating a series of options that will enable us to mitigate any delay in approval. All other aspects of our ONSOLIS NDA were reviewed positively and with no deficiencies noted. I want to congratulate the entire team at BDSI for this tremendous accomplishment."