FDA approves Merck's suvorexant

FDA approved Belsomra suvorexant from Merck & Co. Inc. (NYSE:MRK) to treat insomnia. The pharma said it plans to make the dual orexin receptor antagonist available in the U.S. by late 2014 or early 2015. The launch is contingent on final scheduling by the U.S. Drug Enforcement Agency. In February, the DEA proposed to classify Belsomra as a class IV controlled substance, where class I indicates the highest potential for abuse and class V the lowest.

The recommended starting dose for Belsomra is 10 mg once daily. In its original application, Merck had been seeking approval of a 15 mg dose in elderly patients and a 20 mg dose in non-elderly patients. In July 2013, FDA issued a complete response letter for the product requesting manufacturing studies but no additional clinical studies for a 10 mg starting dose of suvorexant. ...