Why FDA might back lower starting dose of Merck's suvorexant for insomnia
An FDA advisory committee vote may help senior officials in the Division of Neurology Products resolve a disagreement among review staff about the approvability of insomnia candidate suvorexant from Merck & Co. Inc.
The reviewers agreed suvorexant is effective. But in briefing documents prepared for the May 22 meeting, FDA's clinical reviewer concluded the risks of next-day somnolence were comparable to those of approved insomnia drugs, and that risks of driving impairment associated with the lowest doses tested in Phase III - 15 mg in elderly patients and 20 mg in others - could be mitigated with labeling.
In contrast, the lead medical officer wrote a safety review that concluded there were not enough data to understand adverse events associated with the 15 and 20 mg doses. He suggested Merck should go back to the clinic to study a 10 mg dose prior to approval.
The Peripheral and Central Nervous System Drugs Advisory Committee came down on