Merck Provides Update on Development Program for Suvorexant, an Investigational Orexin Receptor Antagonist for the Treatment of Insomnia


February 6, 2012 8:45 am ET

Company Confirms Plans to File NDA for Suvorexant in 2012

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today provided an update on the development program for suvorexant, the
company’s investigational orexin receptor antagonist, which, if
approved, will be a new mechanism for the treatment of insomnia. The two
pivotal Phase III efficacy trials for suvorexant have been completed
and, based on the positive results of these studies, Merck plans to file
a New Drug Application (NDA) for suvorexant with the U.S. Food and Drug
Administration (FDA) in 2012.

Both Phase III studies were multicenter, randomized, double-blind,
placebo-controlled clinical trials that evaluated suvorexant compared to
placebo in adult patients ages 18 years and older. The primary endpoint
was change from baseline in subjective total sleep time and time to
sleep onset, wake time after persistent sleep onset, and latency to
onset of persistent sleep at one and three months. Merck plans to submit
these data for presentation at major medical meetings later this year.

Suvorexant is one of the five major U.S. filings Merck anticipates for
2012 and 2013.

“Suvorexant selectively targets an important pathway involved in helping
to promote sleep and, if approved, will be a new, first-in-class
treatment for patients with insomnia,” said Peter S. Kim, president,
Merck Research Laboratories. “We are enthusiastic about the potential of
this investigational medicine, and look forward to sharing the results
from these studies with the medical community.”

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