Merck provided an update on the development program for suvorexant, the company’s investigational orexin receptor antagonist, which, if approved, will be a new mechanism for the treatment of insomnia. The two pivotal Phase III efficacy trials for suvorexant have been completed and, based on the positive results of these studies, Merck plans to file a New Drug Application (NDA) for suvorexant with the US Food and Drug Administration (FDA) in 2012.
Both Phase III studies were multicenter, randomized, double-blind, placebo-controlled clinical trials that evaluated suvorexant compared to placebo in adult patients ages 18 years and older. The primary endpoint 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 1 and 3 months. Merck plans to submit these data for presentation at major medical meetings later this year.
Suvorexant is one of the five major US filings Merck anticipates for 2012 and 2013.
"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," said Peter S. Kim, president, Merck Research Laboratories. "We are enthusiastic about the potential of this investigational medicine, and look forward to sharing the results from these studies with the medical community."