FDA, Clinical Trial News: Acura / King Pharma, Amylin

Shares of Acura Pharma (NASDAQ:ACUR) are trading down sharply by 45% in after-hours action on news that a joint meeting held today of the Anesthetic / Life Support Drugs and Drug Safety / Risk Management FDA Advisory Committees voted 19-1 against recommending approval for the experimental pain drug, Acurox (oxycodone and niacin), which was designed to deter abuse through the addition of niacin.

Shares of partner King Pharma (NYSE:KG) are trading up 1.4% in after-hours action as the Company is much larger with an established base of products and other pain drug candidates in both late-stage development and already approved for marketing. The FDA issued a Complete Response Letter (CRL) in mid-2009 for Acurox and the FDA Advisory members questioned the benefit of adding niacin and its ability to deter abuse.

After the market close, Amylin Pharma (NASDAQ:AMLN), Eli Lilly (NYSE:LLY) and Alkermes (NASDAQ:ALKS) announced the submission of a reply to a CRL for BYDUREON (exenatide for extended-release injectable suspension), with an expected FDA response as Class 1 (60-day review) or Class 2 resubmission (six-month review) within 14 days. The response by the companies included finalized product labeling, clarification of manufacturing processes, and Risk Evaluation and Mitigation Strategy (REMS).

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