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King ponders next move after FDA judgement
03 Jul 2009
Clinical Research
King Pharmaceuticals and Acura have been told by the US Food and Drug Administration (FDA) that there are potential abuse problems with its painkiller Acurox.
The FDA said in a complete response letter that there were issues regarding the potential abuse deterrent benefits of the drug and both pharmaceutical companies are currently considering their next move.
King stated: "Acura and King are currently evaluating the FDA's complete response letter and at this stage believe they can respond to the issues raised without conducting any additional studies."
The company also said that both King and Acura plan to schedule a meeting with the FDA to discuss the response.
Acurox is a tablet which is designed to treat moderate to severe pain and the companies say it uses Acura's proprietary aversion technology which is designed to deter abuse.
King recently presented information about the safety of Acurox at the 71st annual meeting of the College on Problems of Drug Dependence in Nevada.
