Titan Pharmaceuticals, Inc. today announced that the New Drug Application (NDA) for Probuphine® has been accepted for review and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). Probuphine is a novel, subdermal implant and the first long-acting product designed to deliver six months of the drug buprenorphine hydrochloride following a single treatment. Titan submitted the NDA for the maintenance treatment of opioid dependence in adult patients in October 2012 under Section 505(b)(2) of the Food, Drug and Cosmetic Act and referenced the approved sublingual tablet formulations of buprenorphine.
Priority designation is given to therapies that offer potential major advances in treatment, including improved safety, or provide a treatment where no adequate therapy exists. Based upon the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of April 30, 2013 for FDA action on the NDA.
Source: Titan Pharmaceuticals, Inc. – January 2, 2013