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Acura Pharmaceuticals and King Pharmaceuticals 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
PALATINE, IL and BRISTOL, TN, USA | July 2, 2009 | 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®. 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.
About Acurox® Tablets
Acurox® is a patented, orally administered, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient with a proposed indication for the relief of moderate-to-severe pain. Acurox® utilizes Acura’s proprietary Aversion® Technology, which is designed to deter misuse and abuse by intentional swallowing of excess quantities of tablets, intravenous injection of dissolved tablets and nasal snorting of crushed tablets. The Acurox® Tablets NDA was originally accepted for filing by FDA earlier this year with a priority review classification.
About Acura Pharmaceuticals, Inc.
Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research, development and manufacture of Aversion® (abuse deterrent) Technology product candidates and other innovative abuse deterrent technologies. Acura and King jointly developed Acurox® Tablets and are developing three additional opioid analgesic product candidates utilizing Aversion® Technology pursuant to a 2007 License, Development and Commercialization Agreement.
About King Pharmaceuticals, Inc.
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products and technologies that complement the Company’s focus in specialty-driven markets, particularly neuroscience and hospital. King’s wholly-owned subsidiary, Alpharma, Inc., is also a leader in the development, registration, manufacturing and marketing of pharmaceutical products for food producing animals.
SOURCE: King Pharmaceuticals, Inc. |
