Merck Announces FDA Acceptance of New Drug Application for Suvorexant, an Investigational Insomnia Medicine
November 8, 2012 8:30 am ET
Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today 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.
“The discovery and development of innovative medicines that help
patients is our goal at Merck, and insomnia is a common disorder where
patients are seeking new treatments,” said Darryle D. Schoepp, Ph.D.,
senior vice president and franchise head, Neuroscience and
Ophthalmology, Merck Research Laboratories. “Suvorexant is a novel
mechanism for the treatment of insomnia, and the filing of suvorexant is
an example of Merck’s commitment to patients and to scientific
excellence.”
Merck researchers developed suvorexant to target and block orexins,
chemical messengers that help to keep you awake. By temporarily blocking
the actions of orexins, suvorexant helps to facilitate sleep. If
approved, suvorexant would be the first in a new class of medicines,
called orexin receptor antagonists, for use in patients with difficulty
falling or staying asleep.
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