Suvorexant’s Strike One: Higher Doses Out, More Low Dose Studies In
This article was originally published in The Pink Sheet Daily
Merck’s “complete response” for insomnia drug suvorexant indicates FDA wants drug doses the company has said are ineffective.
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Merck favors the subjective study endpoints, perhaps with an eye toward potential marketing challenges, and the Rozerem experience could haunt Merck’s dreams.
Sponsors may need to be more proactive in reaching out to the agency if they want to avoid the kind of dosing confusion currently facing Merck’s insomnia drug suvorexant, FDA indicates.
Agency will require driving simulation studies for all new sleep aids and is asking sponsors of currently approved products to conduct such trials. FDA is directing zolpidem-containing product manufacturers to make labeling changes based, in part, on driving data submitted for Transcept’s Intermezzo.