Merck & Co. Inc. (MRK: Quote) announced Monday that it has received a Complete Response Letter from the U.S. Food and Drug Administration or FDA regarding the New Drug Application for suvorexant, the company's investigational medicine for the treatment of insomnia. Insomnia is a condition characterized by difficulty falling asleep and/or staying asleep.
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.
The FDA also advised Merck that 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 Perlmutter, president, Merck Research Laboratories.
The company said based on initial review of the letter, it 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. The company said it will discuss with the FDA whether additional studies will be required to support the 5 mg dose.
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by RTT Staff Writer
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