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Merck Announces Phase III Data for Insomnia Medicine

If approved, suvorexant would be first orexin receptor antagonist for sleeping difficulties (Sept. 10)

On September 10, Merck announced new data for suvorexant, an investigational medicine that the company is developing for the treatment of insomnia. The new data are from a 12-month, continuously dosed, placebo-controlled trial that assessed the safety and long-term efficacy of the drug.

Merck presented results from a 2-month discontinuation phase that followed the 12-month study at the 21st Congress of the European Sleep Research Society (ESRS).

Results from the discontinuation phase showed that, after daily use of a consistent dose of suvorexant for 1 year, patients who stopped taking the medicine experienced a return of their sleeping difficulties to levels similar to those reported by patients who received placebo over the course of the trial. Patients who continued to receive suvorexant for the additional 2 months experienced mean improvements in their ability to fall asleep and stay asleep that were consistent with those seen over the first 12 months compared with placebo.

Suvorexant was developed to target and block orexins, chemical messengers that originate from the hypothalamus (an important sleep center in the brain) and help keep people 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 FDA in 2012. If approved, suvorexant would be the first in a new class of medicines — 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.

For more information, visit the Merck Web site.

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