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ACUROX(R) Tablets New Drug Application Accepted For Filing With A Priority Review Classification

Stocks in this article: ACUR

PALATINE, Ill., Feb. 14, 2011 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) today announced that it has been informed by King Pharmaceuticals Research and Development Inc. (King) that King's New Drug Application (NDA) for ACUROX ® (oxycodone HCl) Tablets was accepted for filing by the US Food and Drug Administration (FDA) with a Priority review classification and a Prescription Drug User Fee Act (PDUFA) date of June 17, 2011. In addition to filing acceptance and assignment of a Priority review classification, the FDA's filing communication letter to King also includes preliminary comments about potential review issues relating to an intranasal abuse liability study included in the NDA and requests additional information relating to this study and other issues. The preliminary notice of potential review issues is not indicative of deficiencies that may be identified during the FDA's review of the NDA. No assurance can be given that any issues raised as part of the FDA's review of the ACUROX ® NDA (including the potential review issues in the FDA's filing communication letter) will be addressed to the FDA's satisfaction or that the ACUROX ® NDA will be approved by the FDA.

About ACUROX ® Tablets

ACUROX ® is a patented, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient. ACUROX ® is intended for oral administration with a targeted indication for the relief of moderate to severe pain. ACUROX ® Tablets utilize Acura's patented Aversion ® Technology which is designed to limit or impede opioid abuse via intravenous injection of dissolved tablets and nasal snorting of crushed tablets. ACUROX ® Tablets do not contain niacin.

About Priority Review Classifications

The FDA may assign an NDA a Priority review classification if its assessment of conditions and information available at the time the application is filed indicates the drug product has the potential to provide, among other things, significant improvements compared to marketed products. A Priority review classification by the FDA determines an NDA's review timeline under PDUFA and is not intended to predict FDA approval of a drug or its market acceptance or sales potential.

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