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

“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

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.

About Merck

Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
consumer care and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
healthcare through far-reaching policies, programs and partnerships. For
more information, visit
and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. Such statements may include,
but are not limited to, statements about the benefits of the merger
between Merck and Schering-Plough, including future financial and
operating results, the combined company’s plans, objectives,
expectations and intentions and other statements that are not historical
facts. Such statements are based upon the current beliefs and
expectations of Merck’s management and are subject to significant risks
and uncertainties. Actual results may differ from those set forth in the
forward-looking statements.

The following factors, among others, could cause actual results to
differ from those set forth in the forward-looking statements: the
possibility that all of the expected synergies from the merger of Merck
and Schering-Plough will not be realized, or will not be realized within
the expected time period; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; Merck’s ability to accurately predict future market
conditions; dependence on the effectiveness of Merck’s patents and other
protections for innovative products; and the exposure to litigation
and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck’s 2011 Annual Report on Form 10-K and the company’s other
filings with the Securities and Exchange Commission (SEC) available at
the SEC’s Internet site (

Pam Eisele, 908-423-5042
Lesley Brown, 267-305-3545
Carol Ferguson, 908-423-4465

Unsubscribe from email alerts