Merck : Update on Development Program for Suvorexant, an Investigational Orexin Receptor Antagonist for the Treatment of Insomnia

Feb. 6, 2012 - Company Confirms Plans to File NDA for Suvorexant in 2012 -

Merck (NYSE:MRK), known as MSD outside the United States and Canada, provided an update on the development program for suvorexant, the company's investigational orexin receptor antagonist, which, if approved, will be a new mechanism for the treatment of insomnia. The two pivotal Phase III efficacy trials for suvorexant have been completed and, based on the positive results of these studies, Merck plans to file a New Drug Application (NDA) for suvorexant with the U.S. Food and Drug Administration (FDA) in 2012.

Both Phase III studies were multicenter, randomized, double-blind, placebo-controlled clinical trials that evaluated suvorexant compared to placebo in adult patients ages 18 years and older. The primary endpoint was change from baseline in subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep at one and three months. Merck plans to submit these data for presentation at major medical meetings later this year... Merck's Press Release -

Merck : Results Presented from Phase IIb Clinical Study of its Investigational Insomnia Therapy MK-4305

June 9, 2010 - Data Reported at SLEEP 2010 24th Annual Meeting of the Associated Professional Sleep Societies – Clinical results from a Phase IIb study showed that MK-4305, Merck's investigational dual orexin receptor antagonist, was significantly more effective than placebo (p inf. 0.005) in improving overall sleep efficiency at night one and at the end of week four in patients with primary insomnia. MK-4305 was generally well-tolerated in the study. Orexins are neuropeptides (chemical messengers) that are released by specialized neurons in the hypothalamus region of the brain and are believed to be an important regulator of the brain’s sleep-wake process. The data were presented for the first time at the SLEEP 2010 24th Annual Meeting of the Associated Professional Sleep Societies.

Phase III trials studying the efficacy and safety of MK-4305 in elderly and non-elderly insomnia patients are ongoing. Merck anticipates filing regulatory applications for MK-4305 in 2012.

"Since the discovery and characterization of orexin over the past decade as an important component of the sleep-wake system, Merck has been actively committed to discovering and developing potential interventions for sleep disorders that target the orexin receptors. We are encouraged by these phase II results showing positive effects of MK-4305 in patients with primary insomnia,”... Merck's Press Release -