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Merck: Phase 3 Trial Of BELSOMRA C-IV Meets Primary Efficacy Endpoints

Merck & Co Inc. (MRK) announced Tuesday that a Phase 3 trial evaluating the efficacy and safety of BELSOMRA (suvorexant) C-IV for the treatment of insomnia in people with mild-to-moderate Alzheimer's disease dementia met primary and secondary efficacy endpoints.

BELSOMRA is a first-in-class oral, highly selective antagonist for orexin receptors. The company noted that Orexin is a neurotransmitter found in a specific part of the brain that can help keep a person awake.

The Phase 3 randomized, double-blind, clinical trial evaluated the efficacy and safety of BELSOMRA (suvorexant) 10 mg. For the primary endpoint, 4-weeks of treatment with BELSOMRA improved mean total sleep time by 28.2 minutes versus placebo.

The company presents the results at the 2019 American Academy of Neurology Annual Meeting, held May 4-10 in Philadelphia, PA.

Merck noted that BELSOMRA C-IV 5 mg, 10 mg, 15 mg and 20 mg tablets are currently approved in the United States for treatment of insomnia characterized by difficulties with sleep onset and sleep maintenance.

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