Acura Pharma (ACUR) Receives Preliminary Review Letter from FDA Related to NDA for Acurox(r)

June 23, 2009 9:37 AM EDT

Acura Pharmaceuticals, Inc. (Nasdaq: ACUR) announced today receipt from the U.S. FDA of a review letter related to our New Drug Application for Acurox(r) (oxycodone hydrochloride/niacin) Tablets. On February 22, 2009, Acurox(r) was granted a priority review classification by the FDA with a Prescription Drug User Fee Act 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, we do not believe Acurox(r) 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(r) Tablets will be received.

The Company is a party to an exclusive License Agreement with King Pharmaceuticals Research and Development, Inc., a subsidiary of King Pharmaceuticals, Inc., for the development and commercialization of certain opioid analgesic products utilizing our Aversion(r) Technology in the United States, Canada and Mexico. The License Agreement provides King with an exclusive license for Acurox(r) (oxycodone hydrochloride and niacin) Tablets.

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