Posted by herpills on November 12, 2012, at 21:48:58
New York Business Journal
Date: Thursday, November 8, 2012, 2:44pm ESTMerck researchers developed suvorexant to target and block orexins, chemical messengers that help to keep you awake.
Drugmaker Merck & Co. says the Food and Drug Administration is reviewing the companys new drug application for suvorexant, its investigational insomnia medication.
Merck researchers developed suvorexant to target and block orexins, chemical messengers that help to keep you awake. By temporarily blocking the actions of orexins, suvorexant helps to facilitate sleep. If approved, Merck said 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.
Suvorexant minimizes the morning grogginess common with many sleep aids, according to the Associated Press. In studies, the drugs most common side effects were tiredness and headache, the AP said.
"The discovery and development of innovative medicines that help patients is our goal at Merck, and insomnia is a common disorder where patients are seeking new treatments," said Darryle D. Schoepp, senior vice president and franchise head for neuroscience and ophthalmology at Merck Research Laboratories.
Suvorexant will be evaluated by the Controlled Substance staff of the FDA during review. If approved by the FDA, suvorexant will become available after a schedule assessment and determination has been completed by the U.S. Drug Enforcement Administration, which routinely occurs after FDA approval.
Merck said it conducted two pivotal, three-month efficacy trials that evaluated the ability of suvorexant to help patients fall asleep and stay asleep; a 12-month study, followed by a two-month discontinuation phase, that was designed to assess the safety of suvorexant, while also evaluating its longer term efficacy and the impact of stopping treatment; and two next-day driving studies that provided an assessment of residual effects following evening use of suvorexant.
Merck (NYSE: MRK), based in Whitehouse Station, N.J., said it continuing with plans to seek approval for suvorexant in other countries.
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thread:1031194
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