Merck’s Suvorexant To Face FDA Panel Scrutiny On Next-Day Driving Effects
This article was originally published in The Pink Sheet Daily
The Peripheral and Central Nervous System Drugs Advisory Committee’s May 22 review of the first-in-class insomnia drug will include data from two studies assessing the compound’s residual effects on next-day driving.
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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.
FDA will ask an advisory committee whether Merck’s insomnia drug should employ the tiered dosing schedule proposed for the elderly and non-responders, but the agency seems inclined towards a dose even lower that the ones that were used in Phase III.
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.