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Merck & Co Inc Announces FDA Acceptance Of New Drug Application For Suvorexant, Investigational Insomnia Medicine


Thursday, 8 Nov 2012 08:30am EST 

Merck & Co Inc announced that the New Drug Application (NDA) for suvorexant, the Company's investigational insomnia medicine, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). 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. The Company is continuing with plans to seek approval for suvorexant in other countries around the world. 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.