BioCentury
ARTICLE | Clinical News

Suvorexant regulatory update

May 27, 2013 7:00 AM UTC

FDA's Peripheral and Central Nervous System Drugs Advisory Committee recommended approval of once-daily suvorexant from Merck 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 1 abstention, that starting doses of 15 and 20 mg are safe, but voted 8-7, with 2 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 1 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 might be an appropriate starting dose. Merck evaluated a 10 mg dose in a Phase II trial, but not in its Phase III program. ...