Merck & Co. Inc. (MRK) announced the new Phase III Data for suvorexant, the investigational medicine the compoany is developing for the treatment of insomnia.
The 12-month study was designed to assess the safety of suvorexant, while also evaluating its longer term efficacy. The company said it presented new results from a two-month discontinuation phase that followed the 12-month study at the 21st Congress of the European Sleep Research Society or ESRS.
The company said that the results from the two-month discontinuation phase showed that, after daily use of a consistent dose of suvorexant for one 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.
The company noted that Patients who continued to receive suvorexant for the additional two 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 to placebo. Adverse experiences reported in the two-month discontinuation phase were generally consistent with those reported during the 12-month study.
The company stated that it plans to file a New Drug Application (NDA) for suvorexant with the U.S. Food and Drug Administration or FDA in 2012. If approved, suvorexant would be the first in a new class of medicines, called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep. The company said it anticipates that suvorexant will be evaluated by the Controlled Substance Staff of the FDA.
by RTT Staff Writer
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