Merck's Insomnia Drug Approved for Alzheimer's Patients
Merck (NYSE: MRK) received approval from the U.S. Food and Drug Administration to market its insomnia drug Belsomra (suvorexant) for treating sleep disruption in patients with mild-to-moderate Alzheimer's disease. Belsomra was approved by the FDA for the general population in 2014, but Monday's decision allows Merck to include information on the drug's effectiveness in Alzheimer's patients in its prescribing information.
Last May, Merck reported the results of a phase 3 clinical trial of Belsomra in 285 Alzheimer's patients, announcing that the study had met its primary efficacy endpoint. After four weeks of treatment, total sleep time in the Belsoma group increased 73.4 minutes compared with 45.2 minutes in the placebo group. The most common adverse effect was drowsiness the next day.
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Source Fool.com
