Acura Pharmaceuticals, Inc. Release: New Drug Application Submitted For Acurox(r) Tablets

PALATINE, Ill. and BRISTOL, Tenn., Jan. 2, 2009 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) and King Pharmaceuticals, Inc. (NYSE:KG) today announced that Acura has submitted a New Drug Application (NDA) for Acurox(r) (oxycodone HCl/niacin) Tablets to the U.S. Food and Drug Administration (FDA) including a request for priority review. The FDA is expected to determine whether to accept the NDA for filing and consider the priority review request within 60 days. If approved, Acura and King believe Acurox(r) will be the first FDA approved immediate release opioid analgesic designed to deter swallowing excess quantities of tablets and other common methods of misuse and abuse. According to the National Survey on Drug Use and Health published by the Substance Abuse and Mental Health Services Administration in 2006, immediate-release opioids are abused 10 times more frequently than extended-release opioids.1
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