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New Phase III Data Showed Suvorexant Improved Insomnia

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New data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia, show that the drug 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.

Merck's two studies were multicenter, randomized, double-blind, placebo-controlled trials of suvorexant in patients with primary insomnia (1,021 and 1,009 treated patients in Trial 1 and Trial 2, respectively). A high and a low dose of suvorexant were studied in each trial.  The high dose evaluated suvorexant 40 mg in patients 18- to 64-years-old and suvorexant 30 mg in patients 65 years and older, and the low dose assessed suvorexant 20 mg in patients 18-64 years and suvorexant 15 mg in patients 65 years and older.  Patients were randomized to receive one of the suvorexant doses or placebo over a three-month period. The results reported below are for the combined primary endpoint dose of 40 mg and 30 mg (383 patients in Trial 1 and 387 patients in Trial 2 were treated with the high dose compared to 384 and 383 on placebo, respectively). 

In both trials, on all primary subjective measures, patients who took suvorexant fell asleep significantly faster and stayed asleep longer compared to patients taking placebo at one month and three months (p<0.003). Suvorexant also significantly reduced the time it took patients to fall into continuous sleep and decreased the time patients spent awake during the night at one month and three months (primary endpoints), and as early as night one (a secondary endpoint) (p<0.001), except for Month 3 in Trial 2, at which point the difference in time to fall into continuous sleep did not reach statistical significance. 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. Merck plans to present additional results from its two pivotal Phase III efficacy trials later this year.      

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."

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.

"We specifically focused our research efforts on insomnia because it is an area of significant unmet medical need," said Darryle D. Schoepp, Ph.D., senior vice president 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."

Source: Merck

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