The products being returned are oxycodone hydrochloride with acetaminophen, hydrocodone bitartrate with acetaminophen and an undisclosed opioid. The hydrocodone product is the most advanced in development, with a clinical study completed in February 2012 that reportedly 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 (FDA) in May 2012 in which the FDA agreed to a development program for this product generally consistent with that used for another drug using the AVERSION technology, known as OXECTA (oxycodone hydrochloride) Tablets CII.  

 

"We are pleased to regain control of these tamper-resistant opioid products because we continue to believe they hold promise in combating widespread prescription opioid abuse," said Bob Jones, president and CEO of Acura Pharmaceuticals. "We will evaluate our strategy for these products over the coming months, including possible partnering with alternative strategic partners, and will work with Pfizer to exercise our rights under the Pfizer agreement for the transition of these products back to us."  

 

As for OXECTA, that drug is being commercialized by Pfizer and Pfizer will retain all rights and obligations to OXECTA under the license agreement.