Merck Sharpe and Dohme to file for approval of new insomnia drug

Merck Sharpe and Dohme has announced plans to apply for regulatory approval of a developmental therapy for insomnia, based on positive clinical trial data.

A new drug application will be submitted to the US Food and Drug Administration (FDA) for suvorexant, the company's investigational orexin receptor antagonist, at some point this year, thanks to the drug's performance in a pair of phase III studies.

Trials have shown that suvorexant is able to deliver advantages in terms of subjective total sleep duration, time to sleep onset and wake time after persistent sleep onset compared to placebo, having been tested among adult patients.

It offers a new mechanism for the treatment of the disease and is one of five major FDA filings planned by the company over 2012 and 2013.

Peter Kim, president of Merck Research Laboratories, said: "We are enthusiastic about the potential of this investigational medicine and look forward to sharing the results from these studies with the medical community."

This comes after the company announced its financial results for 2011 earlier this month, reporting year-on-year growth of four percent.