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Acura Pharmaceuticals Announces Update on AVERSION Products


Acura Pharmaceuticals (NASDAQ: ACUR) announced Friday that Pfizer (NYSE: PFE) provided notice on July 26, 2012 that it is exercising its right to terminate the license to three development stage products using Acura's AVERSION Technology and return such products to Acura. The termination will become effective in 12 months under the terms of our License Agreement with a subsidiary of Pfizer. A fourth product utilizing Acura's AVERSION Technology, OXECTA (oxycodone hydrochloride) Tablets CII, is being commercialized by Pfizer and Pfizer will retain all rights and obligations to OXECTA under the License Agreement.

The products being returned are oxycodone hydrochloride with acetaminophen, hydrocodone bitartrate with acetaminophen and another undisclosed opioid. The hydrocodone product is the most advanced in development, with a clinical study completed in February 2012, which demonstrated bioequivalence to its reference listed drug. This product also was the subject of a pre-IND meeting held with the U.S. Food and Drug Administration in May 2012 in which the FDA agreed to a development program for this product generally consistent with that used for OXECTA.

Posted-In: News FDA After-Hours Center


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