FDA approves BDSI's NDA for Bunavail

RALEIGH, N.C. — BioDelivery Sciences International on Monday announced that the Food and Drug Administration approved its new drug application for Bunavail (buprenorphine and naloxone) buccal film (CIII). The drug is used as a maintenance treatment of opioid dependence. The company noted that it also should be used as part of a complete treatment plan to include counseling and psychosocial support.



Bunavail is the first and only formulation of buprenorphine and naloxone for buccal (inside of the cheek) administration, BDSI said.



"Bunavail is a novel treatment approach for the more than two million people in the United States afflicted with opioid dependence," said Gregory Sullivan, M.D., principal investigator of the Phase 3 Bunavail safety study and an addiction specialist and Medical Director of Parkway Medical Center in Birmingham, Ala. "Bunavail utilizes advanced drug delivery technology to fulfill an important need for treatment options with improved drug absorption and patient convenience, and as such, may help to address some of the challenges associated with sublingual administration and possibly help improve treatment compliance."



BDSI plans to launch the product in late third-quarter 2014 and estimates the peak sales potention of the drug to reach up to $250 million.