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Acurox Approval Could Be Impossible Given Combination Drug Regs

Executive Summary

By determining that the niacin component of King Pharmaceuticals/Acura Pharmaceuticals' Acurox, an abuse-resistant formulation of immediate-release oxycodone, is ineffective at deterring oral abuse of the opioid product, an FDA advisory committee may have precluded the possibility of approval, given the regulations governing combination products

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Analgesic drugs have reached a painful point. Unwanted side effects and abuse potential have made existing drug categories such as non-steroidal anti-inflammatories and opioids unappealing prescriptions for patients in chronic pain. But a new class of antibodies that inhibit the crucial protein nerve growth factor could spell relief for millions of chronic pain sufferers - if they can demonstrate safety and efficacy

Acurox Drops Niacin, But King And Acura Need New Study For Reformulation

Firms will submit NDA for a revised version of their oxycodone formulation Acurox that offers impediments to abuse by snorting or injection but does not contain niacin, which FDA says is ineffective at preventing oral abuse.

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