Merck (NYSE: MRK) is to file a new drug application with the U.S. Food and Drug Administration following successful Phase III clinical trial results.
The Whitehouse Station, New Jersey pharmaceutical company’s drug, Suvorexant, generated positive results in clinical trials that sought to prove the efficacy of the drug.
Peter S. Kim, president of Merck Research Laboratories said: “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,” according to a statement from the company.
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Although there are several insomnia drugs on the market already, Merck’s drug takes a different approach. Instead of depressing the central nervous system, which can lead to excessive drowsiness the next morning, it focuses on orexin receptors in the brain. Orexin receptors were found to be linked to a genetic mutation found to cause narcolepsy in dogs as well as humans.
Last year, the U.S. Food and Drug Administration approved Transcept Pharmaceuticals‘ drug Intermezzo, the first drug approved for treating the version of insomnia typified by people waking up in the middle of the night and not being able to get back to sleep, a statement from the FDA said. Intermezzo is a lower dose version of zolpidem tartrate, approveby US regulators in 1992 as Ambien.
The National Center for Sleep Disorders Research at the National Institutes of Health said 30 percent to 40 percent of Americans say they suffer at least some of the symptoms of insomnia.