Merck announced that the New Drug Application (NDA) for suvorexant, the company’s investigational insomnia medicine, has been accepted for standard review by the FDA. Suvorexant targets and blocks orexins, chemical messengers that help to keep an individual awake; by temporarily blocking the actions of orexins, suvorexant helps to facilitate sleep.
The NDA for suvorexant was based on data from a broad clinical development program, including: two pivotal, three-month efficacy trials that evaluated the ability of suvorexant to help patients fall asleep and stay asleep; a 12-month study, followed by a two-month discontinuation phase, that was designed to assess the safety of suvorexant, while also evaluating its longer term efficacy and the impact of stopping treatment; and two next-day driving studies that provided an assessment of residual effects following evening use of suvorexant.
Suvorexant will be evaluated by the Controlled Substance Staff of the FDA during NDA review. If approved by the FDA, suvorexant will become available after a schedule assessment and determination has been completed by the U.S. Drug Enforcement Administration, which routinely occurs after FDA approval.
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