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Why FDA might back lower starting dose of Merck's suvorexant for insomnia
Monday, June 3, 2013
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.
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