FDA Advisory Committees vote against approval of Acurox NDA

Apr 23 2010

Acura Pharmaceuticals, Inc. (Nasdaq: ACUR) and King Pharmaceuticals®, Inc. (NYSE: KG) today announced that the U.S. Food and Drug Administration's (FDA) Anesthetic and Life Support Drugs and Drug Safety and Risk Management Committees voted that they do not have enough evidence to support the approval of the New Drug Application (NDA) for Acurox® (oxycodone HCl and niacin) Tablets for the treatment of moderate to severe pain, considering the deterrent effects of niacin as well as the potential deterrent effects of the other features specific to Acurox®.  The addition of niacin to Acurox® was central to the deliberations. The FDA is not bound by the Advisory Committees' recommendation, but may take its advice into consideration when evaluating the NDA for Acurox® Tablets. Acura and King will work with the FDA to determine the next steps for the Acurox® development program.