WHITEHOUSE STATION (dpa-AFX) - Drugmaker Merck & Co. Inc. (MRK) said Monday that based on the positive results from two pivotal Phase III efficacy trials for its experimental insomnia drug Suvorexant, it plans to file a new drug application or NDA with the U.S. Food and Drug Administration in 2012. Merck anticipates Suvorexant as one of the five major U.S. filings for 2012 and 2013. Suvorexant is Merck's investigational orexin receptor antagonist, which, if approved, will be a new mechanism for the treatment of insomnia. Merck said that both the late-stage studies for Suvorexant were multi-center, randomized, double-blind, placebo-controlled clinical trials that evaluated suvorexant compared to placebo in adult patients aged 18 years and older. The primary endpoint of the trials 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. Peter Kim, President of Merck Research Laboratories said, 'Suvorexant selectively targets an important pathway involved in helping to promote sleep and, if approved, will be a new, first-in-class treatment for patients with insomnia. We are enthusiastic about the potential of this investigational medicine, and look forward to sharing the results from these studies with the medical community.' The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. In Monday's regular session, MRK is trading at $38.33, down $0.04 or 0.10 percent on a volume of 186,778 shares.
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© 2012 AFX News
