FDA likely to delay Acura's abuse-deterring painkiller

Acura Pharmaceuticals Inc. and King Pharmaceuticals Inc. said U.S. regulators have issued a complete response letter on its application for a painkiller designed to curb abuse.

The letter from the U.S. Food and Drug Administration raises issues regarding the potential abuse deterrent benefits of the drug, Acurox, the companies said today in a statement.

King, based in Bristol, Tennessee, and Acura, based in Palatine, said on June 23 that they expect the FDA to delay a decision on Acurox's approval, missing a previously announced deadline of June 30. The companies said they are currently evaluating the FDA's complete response letter, and believe they can respond to the issues raised without conducting additional studies.

Acurox is a short-acting oxycodone pill that contains niacin, a chemical that causes unpleasant side effects, including skin flushing, if more than the recommended two-tablet dose is taken.