FDA advisers back approval of Merck's insomnia drug at lower doses

05/24/2013 | MedCityNews.com · PharmaTimes (U.K.)

An FDA advisory panel recommended the approval of Merck's insomnia drug suvorexant but only at lower doses, essentially agreeing with concerns previously raised by the agency's staff scientists that higher doses of the drug may cause dangerous next-day drowsiness. The panel voted 13-3, with one abstention that the drug is safe for elderly and non-elderly patients at 15 mg and 20 mg, respectively. The advisers, however, voted 8-7, with two abstentions, that suvorexant is not safe for elderly patients at 30 mg or for non-elderly patients at 40 mg.

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MedCityNews.com · PharmaTimes (U.K.)

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