Merck plans US filing for insomnia drug this year
This article was originally published in Scrip
Executive Summary
US pharma Merck revealed on 6 February that it plans to file its new drug application (NDA) with the US FDA this year for the company's experimental insomnia medicine suvorexant (MK-4305), an orexin receptor antagonist, based on the results of its now completed multicentre, randomised, double-blind, placebo-controlled Phase III trials, which evaluated the agent against placebo in adults 18 years or older.