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


July 1, 2013 7:00 am ET

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.

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