On Wednesday, May 22, the FDA Peripheral and Central Nervous System Drugs Advisory Committee discussed a new drug application for suvorexant tablets (NDA #204569), which was submitted by Merck Sharp and Dohme Corp., Worldwide Regulatory Group. The proposed indication for suvorexant, an orexin receptor antagonist, is for insomnia characterized by difficulties with sleep onset and/or maintenance. The panel voted 13 to 3 in favor of sending the FDA a positive recommendation on marketing approval for suvorexant, the Los Angeles Times reported. However, the panel recommended lower dosages than were proposed in the application due to concerns about potential next-day drowsiness in some patients.
According to a Merck statement, “If approved by the FDA, suvorexant will become available after a schedule assessment and determination has been completed by the U.S. Drug Enforcement Administration, which typically takes place after FDA approval.” The FDA will consider the advisory committee’s recommendations as it completes its review of the NDA for suvorexant. Merck anticipates an FDA decision by the middle of the year.