Panel backs Merck's suvorexant

FDA's Peripheral and Central Nervous System Drugs Advisory Committee recommended approval of once-daily suvorexant from Merck & Co. Inc. (NYSE:MRK) to treat insomnia. The panel concluded suvorexant is an effective sleep aid but suggested it should be given at lower starting doses than those Merck has proposed. The pharma is seeking a label recommending use of 20-40 mg suvorexant in non-elderly patients and 15-30 mg in elderly patients.

The panel voted 13-3, with one abstention, that starting doses of 20 mg and 15 mg are safe, but voted 8-7, with two abstentions, against the safety of doses up to 40 mg in non-elderly patients and 30 mg in the elderly because of concerns about daytime somnolence and narcolepsy-like syndrome. The advisory committee also voted 11-5, with one abstention, that Merck should not have to conduct additional pre-approval studies of a 10 mg dose, which FDA reviewers had suggested in briefing documents on Monday might be an appropriate starting dose. Merck evaluated a 10 mg dose in a Phase II trial, but not in its Phase III program (see BioCentury Extra, May 20). ...