Merck announced that results from two Phase III efficacy trials for suvorexant, an investigational medicine the company is developing for the treatment of insomnia, show 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 3-month time point compared to placebo. According to the results presented at the SLEEP 2012 meeting in Boston last week, suvorexant met statistical significance for all primary endpoints except for one measurement at month 3 in one of the trials.
“This investigational drug targets insomnia in a way that is different from other medicines,” said Andrew D. Krystal, MD, professor of psychiatry and behavioral sciences at 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. “
Additional data presented revealed that sleepiness and headache were the most common adverse events reported at an incidence of greater than or equal to 5% and more often than placebo. Other data presented included results that demonstrated the effects of suvorexant after daily dosing for a least a year.
Merck plans to present additional results from its two multicenter, randomized, double-blind, placebo-controlled Phase III efficacy trials later this year.
Merck developed suvorexant to target and block orexins, chemical messengers that originate from the hypothalamus that help keep people awake. By blocking the actions of orexins, suvorexant helps facilitate sleep.
The company plans to file a New Drug Application (NDA) for suvorexant with the US 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.