Acura (ACUR) & King Pharmaceuticals (KG) Receive Complete Response Letter From FDA for Acurox
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Acura Pharmaceuticals, Inc. (Nasdaq: ACUR) and King Pharmaceuticals, Inc. (NYSE: KG) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the New Drug Application (NDA) for Acurox (oxycodone HC1, USP and niacin, USP) Tablets CII, an immediate release product intended for the relief of moderate-to-severe pain.
The Complete Response Letter raises issues regarding the potential abuse deterrent benefits of Acurox(R). Acura and King are currently evaluating the FDA's Complete Response Letter, and at this stage believe they can respond to the issues raised without conducting any additional studies. The Companies plan to meet with the FDA following submission of their response.
Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research, development and manufacture of Aversion(R) (abuse deterrent) Technology product candidates and other innovative abuse deterrent technologies. Acura and King jointly developed Acurox(R) Tablets and are developing three additional opioid analgesic product candidates utilizing Aversion(R) Technology pursuant to a 2007 License, Development and Commercialization Agreement.[SM]
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