logo
Share SHARE
FONT-SIZE Plus   Neg

Merck Announces New Phase III Data For Suvorexant - Quick Facts

Merck & Co. Inc. (MRK: Quote) 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

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Gas explosion in Fresno in California injured 11 people on Friday afternoon. Pacific Gas and Electric Co. (PG&E) said workers who are not affiliated with the company have struck a 12-inch natural gas transmission pipeline and the gas leaked was ignited due to the dig-in. Verizon Communications' FiOS TV service has modified its programming bundles and will now offer new packages so that users can subscribe only for channels they prefer to watch. Instagram, the photo sharing app owned by Facebook, has updated its community guidelines to disallow nudity and harassment in uploaded photos and pictures, as well as cyber bullying.
comments powered by Disqus
RELATED NEWS
Trade MRK now with 
Follow RTT