Belsomra

Treatment for Insomnia

Update: Belsomra (suvorexant) Now FDA Approved - August 13, 2014

Merck Receives Complete Response Letter for Suvorexant, Merck’s Investigational Medicine for Insomnia

WHITEHOUSE STATION, N.J., July 1, 2013--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application for suvorexant, Merck’s investigational medicine for the treatment of insomnia.

In the Complete Response Letter, the FDA advised Merck that:

•the efficacy of suvorexant has been established at doses of 10 mg to 40 mg in elderly and non-elderly adult patients;
•10 mg should be the starting dose for most patients, and must be available before suvorexant can be approved;
•15 mg and 20 mg doses would be appropriate in patients in whom the 10 mg dose is well-tolerated but not effective; and,
•for patients taking concomitant moderate CYP3A4 inhibitors, a 5 mg dose would be necessary.
In addition, the FDA determined that the safety data do not support the approval of suvorexant 30 mg and 40 mg.

“We will evaluate the requests outlined in the Complete Response Letter, and expect thereafter to work expeditiously with the FDA to make suvorexant available as a new treatment option for patients suffering from insomnia,” said Roger M. Perlmutter, M.D., Ph.D., president, Merck Research Laboratories.

Based on initial review of the letter, Merck has determined that additional clinical studies of suvorexant 10 mg will not be necessary. However, manufacturing studies will be required to advance the 10 mg dosage form. Merck will discuss with the FDA whether additional studies will be required to support the 5 mg dose.

As previously disclosed, both FDA approval and a separate scheduling determination by the U.S. Drug Enforcement Administration are required before Merck can introduce suvorexant in the United States.

Insomnia is a condition characterized by difficulty falling asleep and/or staying asleep. Today, insomnia affects up to a third of adults and there is a clear need for additional treatment options.

If approved, suvorexant would be the first in a new class of medicines, called orexin receptor antagonists, for use in patients with insomnia. Suvorexant’s novel mechanism is distinct from current treatments. Merck researchers developed suvorexant to facilitate sleep by blocking the action of orexins, which are neurotransmitters in the brain that help to keep a person awake.

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 www.merck.com 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. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent 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 2012 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 (www.sec.gov).

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Posted: July 2013

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