Merck & Co. Inc. (MRK) on Wednesday announced new data from two pivotal late-stage clinical trials for its experimental insomnia drug Suvorexant, saying that the drug improved patients' ability to fall asleep and also helped them remain asleep longer. The drugmaker said it remains on track to file a new drug application for the drug in 2012.
Merck noted that suvorexant met statistical significance for all primary endpoints, except for one measurement at the third month in one of the Phase III trials. These data were presented by the company today at SLEEP 2012, the 26th Annual Meeting of the Associated Professional Sleep Societies in Boston.
Suvorexant is Merck's investigational orexin receptor antagonist, which, if approved, will be a new mechanism for the treatment of insomnia. The company anticipates suvorexant as one of its six major filings planned for 2012 and 2013.
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.
In both the studies, suvorexant significantly reduced the time taken by patients to fall asleep and increased the time patients stayed asleep as early as the first night and at the three-month time point compared to placebo.
Andrew Krystal, professor of Psychiatry and Behavioral Sciences, Duke University Medical Center said, "This investigational drug targets insomnia in a way that is different from other medicines. The potential for a new and different option would be welcome by patients with insomnia who cannot sleep through the night."
Merck noted that on all primary subjective measures in both trials, patients who took suvorexant fell asleep significantly faster and remained asleep longer compared to patients taking placebo at one month and three months.
On the objective measures, suvorexant significantly reduced the time taken by patients to fall into continuous sleep and decreased the time patients spent awake during the night at one month and three months - the primary endpoints, and as early as night one - a secondary endpoint.
This was except for Month 3 in the second trial, at which point the difference in time to fall into continuous sleep did not reach statistical significance.
Merck plans to present additional results from its two pivotal Phase III efficacy trials later this year.
In Wednesday's regular session, MRK is trading at $38.57, up $0.14 or 0.36 percent on a volume of 140,487 shares.
by RTT Staff Writer
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