Key Developments For Acura Pharmaceuticals, Inc.
Acura Pharmaceuticals, Inc. (ACUR.O) (Consolidated Issue listed on NASDAQ Capital Market)
Acura Pharmaceuticals, Inc. And King Pharmaceuticals, Inc. Provide Update On Acurox NDA
Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. announced that they met with the U.S. Food and Drug Administration (FDA) on September 2, 2009 to discuss the FDA`s June 30, 2009 Complete Response Letter regarding the New Drug Application for Acurox (oxycodone HCl and niacin) Tablets CII (NDA). The FDA and the Companies agreed to take the NDA to an FDA Advisory Committee to consider the evidence to support the potential opioid abuse deterrent effects of Acurox Tablets. The FDA indicated that no new clinical trials are required at this time. The FDA has not yet set a meeting date for the Advisory Committee`s review of the NDA. The Companies do not expect the meeting to be convened before the end of this year.
Acura Pharmaceuticals, Inc. Submits Acurox Briefing Package To FDA
Acura Pharmaceuticals, Inc. announced that it has submitted a briefing package to the U.S. Food and Drug Administration (FDA) addressing the issues raised in the FDA's June 30, 2009 Complete Response Letter (CRL) related to the New Drug Application (NDA) for Acurox (oxycodone HCl/niacin) Tablets. Acurox is an immediate release tablet with a proposed indication for the relief of moderate to severe pain. Acurox incorporates Acura's Aversion Technology and is intended to discourage product misuse and abuse. Acura and King, its exclusive licensee in the United States, Canada and Mexico, are developing Acurox and three additional opioid analgesic products utilizing Aversion Technology.
Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. Receives FDA Complete Response Letter Regarding Acurox
Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. announced 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. Receives Preliminary Review Letter From FDA Regarding Acurox
Acura Pharmaceuticals, Inc. announced the receipt from the U.S. Food and Drug Administration (FDA) of a review letter related to its New Drug Application (NDA) for Acurox (oxycodone hydrochloride/niacin) Tablets. On February 22, 2009, Acurox was granted a priority review classification by the FDA with a Prescription Drug User Fee Act (PDUFA) date of June 30, 2009. FDA stated in the review letter that their comments are preliminary, subject to change, and do not reflect a final decision on the information reviewed or a review of the entire NDA. Based on this review letter, the Company do not believe Acurox Tablets will receive NDA approval on the PDUFA date. As previously disclosed in the Company's filings with the Securities and Exchange Commission, no assurance can be given that FDA approval of the NDA for Acurox Tablets will be received.
King Pharmaceuticals, Inc. and Acura Pharmaceuticals, Inc. Announces Excess Oral Doses of Acurox Tablets are Disliked by Subjects with a History of Opioid Abuse
King Pharmaceuticals, Inc. and Acura Pharmaceuticals, Inc. announced the results from an oral abuse liability study of Acurox (oxycodone HCl/niacin) Tablets, AP-ADF-111 (Study 111), at the American Society of Addiction Medicine`s (ASAM) Medical-Scientific Conference. The results of Study 111 demonstrate that Acurox Tablets are disliked among people with a history of opioid abuse compared to oxycodone HC1 tablets alone, when excess doses are swallowed. King and Acura are jointly developing Acurox Tablets whose New Drug Application has been granted a priority review classification by The U.S. Food and Drug Administration (FDA). The companies expect a response from the FDA by June 30, 2009. Study 111 - A Phase II, Single-Center, Randomized, Double-Blind Assessment of the Abuse Liability of Oxycodone HC1/Niacin Tablets (Acurox Tablets) in Subjects with a History of Opioid Abuse Acurox Tablets contain a unique composition of oxycodone HCl, niacin, and essential functional inactive ingredients, and are intended to relieve moderate-to-severe pain while deterring common methods of prescription drug abuse including intentionally swallowing excess quantities of tablets, crushing and snorting tablets, and dissolving tablets for injection. Niacin is well tolerated at the recommended two-tablet dose, however, as doses are escalated, niacin induces increasingly unpleasant, dysphoric, yet temporary, effects.
