King submits ACUROX NDA to FDA

King Pharmaceuticals®, Inc. (NYSE: KG) and Acura Pharmaceuticals, Inc. (Nasdaq: ACUR) today announced that King has submitted a New Drug Application (NDA) for ACUROX® (oxycodone HCl) Tablets to the U.S. Food and Drug Administration (FDA), including a request for priority review classification. ACUROX® is an immediate release tablet containing oxycodone HCl intended for the relief of moderate to severe pain. ACUROX® utilizes Acura's patented Aversion® Technology which is designed to deter opioid abuse by intravenous injection of dissolved tablets and nasal snorting of crushed tablets. ACUROX® does not contain niacin. A separate NDA submission for ACUROX® with Niacin Tablets is subject to an FDA Complete Response Letter. Further details on the response to this FDA action letter will be provided at a later date.

The FDA is expected to determine whether to accept the NDA for ACUROX® for filing and consider the priority review request within 60 days.

SOURCE King Pharmaceuticals(R), Inc.; Acura Pharmaceuticals, Inc.