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Published on 4 March 2009

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Priority review for new pain drug

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Two leading pharmaceutical companies have said that US health regulators have granted a priority review of their experimental pain drug Acurox.

The Food and Drug Administration (FDA) has set a target date of June 30 to review whether the new drug Acurox, which has been created by Acura Pharmaceuticals and King Pharmaceuticals, will be approved.

Under the Prescription Drug User Fee Act (PDUFA) the FDA has made the review of the drug, which includes the powerful oxycodone pain medicine, a top priority – meaning it now has just six months to make a decision.

The review is granted for products that are considered to be more advanced over existing therapies and Acurox, which contains components designed to thwart prescription drug abuse, common with opioid pain drugs, is believed to be one step ahead of existing pain relief alternatives.

Tennessee based King announced in October last year that it was signing a deal to use Acura’s Aversion abuse-deterrent technology. It has now applied this technology to three opioid drugs, including Acurox tablets.

Copyright Press Association 2009

Food and Drug Administration



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