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BOSTON — Merck on Wednesday released new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.
Merck expects to file a new drug application to the Food and Drug Administration in 2012. 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.
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. "This investigational drug targets insomnia in a way that is different from other medicines," stated Andrew Krystal, 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."
“We specifically focused our research efforts on insomnia because it is an area of significant unmet medical need,” commented Darryle Schoepp, SVP and head of neuroscience and ophthalmology franchise, Merck Research Laboratories. “Suvorexant approaches insomnia differently than other medicines because it helps patients to sleep by targeting and blocking orexins, which play a role in keeping people awake. We’re excited about the Phase III results and the potential of suvorexant to become the first in a new class of medicines to help patients with insomnia.”
"We've pointed out that we have good sleep offset efficacy, good sleep maintenance efficacy, lack of meaningful next-day residual effects and a safety profile allowing for chronic use, and about 30% of the patients who are in this market need chronic sleep therapy," noted Kenneth Frazier, Merck chairman, CEO, president and president of global human health, during a recent conference call with analysts. "Suvorexant comes to market in a way that's differentiated for people who have to travel, people who have to use sleep medication, not having that drowsiness. Those next-day residual effects are important to them. We have data with respect to drivers, where we see that it really does make a difference."