Complete Response Letter from FDA to Merck regarding suvorexant as a treatment for Insomnia
Merck inc., announced that the company has received a Complete Response Letter from the 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.
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