FDA advisory committees say Acurox approval lacks sufficient evidence

PALATINE, Ill. Two advisory committees of the Food and Drug Administration don’t have enough evidence to recommend approval of an opiate made by King Pharmaceuticals and Acura Pharmaceuticals designed to deter drug abusers, the two drug makers said Thursday.

King and Acura said the FDA’s Anesthetic and Life Support Drugs and Drug Safety and Risk Management committees would not recommend approval for Acurox (oxycodone hydrochloride and niacin). The niacin added to Acurox is meant to minimize the potential for oral abuse of the drug.

The FDA is not bound by advisory committee recommendations, but may take them into account when deciding whether to approve a drug.

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