FDA issues complete response for Merck's suvorexant

FDA issued a complete response letter for once-daily suvorexant from Merck & Co. Inc. (NYSE:MRK) to treat insomnia. In the letter, the agency requested manufacturing studies but no additional clinical studies for a 10 mg starting dose of suvorexant. Merck was seeking a label recommending use of 20-40 mg doses of the compound in non-elderly patients and 15-30 mg in elderly patients. According to the pharma, FDA said suvorexant's efficacy has been established at doses of 10-40 mg in both elderly and non-elderly adults but safety data do not support approval of the 30 or 40 mg doses. The pharma declined to provide details, including a timeline for when it expects to complete the manufacturing studies. ...