The drug company Merck announced today that they have received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) in regards of their New Drug Application for an insomnia medication.
Insomnia is a medical condition where the person has difficulty falling asleep and/or staying asleep. Merck stated the sleep condition affects up to a third of adults.
According to Merck's news release, the FDA told the company that the safety data is not sufficient to approve "suvorexant 30 mg and 40 mg" insomnia treatment.
In the Complete Response Letter the FDA advised Merck of the following:
1. The efficacy of suvorexant has been established at doses of 10 mg to 40 mg in elderly and non-elderly adult patients.
2. 10 mg should be the starting dose for most patients and must be available before suvorexant can be approved.
3. 15 mg and 20 mg doses would be appropriate in patients in whom the 10 mg dose is well-tolerated but not effective.
4. And patients taking concomitant moderate CYP3A4 inhibitors a 5 mg dose would be necessary.
"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," Roger M. Perlmutter M.D. Ph.D. president Merck Research Laboratories, said in athe news release.
Merck stated that the company will not research additional clinical studies of suvorexant 10 mg, but will start manufacturing studies to advance the 10 mg dosage form. The global healthcare leader will discuss with FDA whether additional studies will be required to support the 5 mg dose of the insomnia medication.
"If approved suvorexant would be the first in a new class of medicines called orexin receptor antagonists for use in patients with insomnia...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," Merck said.
Merck needs FDA approval and a separate scheduling determination by the U.S. Drug Enforcement Administration before the medication can be introduced into the market.
To view the company's full news release, click here.
