King, Acura Say FDA Does Not Need New Acurox Trial

Fri, 09/04/2009 - 6:29am
NEW YORK (AP) — King Pharmaceuticals Inc. and Acura Pharmaceuticals Inc. said Friday they don't expect to have to run new clinical trials of an abuse-resistant pain drug in order to gain Food and Drug Administration approval. The agency and the two companies met Wednesday, and King and Acura said the FDA indicated further testing of the drug, called Acurox, are not required at this time. The companies said they agreed to discuss the design and potential benefits of the drug with an FDA advisory committee. That meeting will probably not happen until next year. Acurox is a painkiller containing oxycodone, a morphine derivative that is the active ingredient in the drug OxyContin. The drug includes features developed by Acura that will prevent abuse, the companies say. The FDA declined to approve the drug in June, saying it had concerns about the abuse deterrent benefits. Palatine, Ill.-based Acura's Aversion Technology is intended to discourage people from getting high by overdosing on Acurox, or by crushing the pills and snorting them, or dissolving and injecting them. If the drug is exposed to water or alcohol, Acura says, the oxycodone gets trapped in a gel mixture, which makes it difficult to get into a needle. If snorted, it creates a burning, irritating sensation in the nose, and because the drug also contains niacin, excess doses cause symptoms such as warmth or flushing, itching, sweating, chills, headache and discomfort.



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