Merck’s Suvorexant To Face FDA Panel Scrutiny On Next-Day Driving Effects

03 Apr 2013

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.

The residual effects of Merck & Co. Inc.’s first-in-class insomnia agent suvorexant on next-day driving are likely to be a key focus of an FDA advisory committee review, given the agency’s recent edict that driving simulation studies be conducted for all sleep treatments.

FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will discuss the suvorexant NDA on May 22, the agency announced...