Acura Pharmaceuticals Announces Update on AVERSION Products

Loading...
Loading...
Acura Pharmaceuticals
ACUR
announced Friday that Pfizer
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.
Market News and Data brought to you by Benzinga APIs
Posted In: NewsFDAAfter-Hours Center
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...