Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia. In the studies, suvorexant significantly reduced the time it took patients to fall asleep and increased the time that patients stayed asleep as early as the first night and at the three-month time point compared to placebo. The investigational medicine met statistical significance for all primary endpoints except for one measurement at Month 3 in one of the trials. These late-breaking data were presented here today at SLEEP 2012, the 26 th Annual Meeting of the Associated Professional Sleep Societies.
"This investigational drug targets insomnia in a way that is different from other medicines," said Andrew D. Krystal, M.D., professor of Psychiatry and Behavioral Sciences, Duke University Medical Center. "The potential for a new and different option would be welcome by patients with insomnia who cannot sleep through the night."
Further efficacy and safety results from the Phase III clinical program for suvorexant were presented at the SLEEP meeting. In these two pivotal Phase III efficacy trials, the most common adverse events (AEs) reported at an incidence of greater than or equal to five percent and more often than placebo were sleepiness and headache. Other data presented included results that demonstrated the effects of suvorexant after daily dosing for at least a year (abstract 0641, oral session O22). This is one of the longest continuously dosed, placebo-controlled trials of a sleep medication ever conducted. Results from a driving study in elderly patients also were presented (abstract 0670, poster 192). Merck plans to present additional results from its two pivotal Phase III efficacy trials later this year.
Merck researchers developed suvorexant to target and block orexins, chemical messengers that originate from the hypothalamus (an important sleep center in the brain) that help to keep you awake. By blocking the actions of orexins, suvorexant helps to facilitate sleep. Merck plans to file a New Drug Application (NDA) for suvorexant with the U.S. Food and Drug Administration (FDA) in 2012, making it one of the company’s six major filings planned for 2012 and 2013. If approved, suvorexant would be the first medicine approved in a new class of medicines, called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep. Merck anticipates that suvorexant will be evaluated by the Controlled Substance Staff of the FDA.
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