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Merck & Co prepares to file first-in-class insomnia drug for US approval

Will submit orexin receptor antagonist suvorexant to the FDA later this year

Merck & Co is planning to submit its potential first-in-class insomnia treatment suvorexant for US approval later this year.

If approved suvorexant would enter a US sleep drug market worth an estimated $2bn in 2010, with sales led by Sanofi's Ambien CR and Sunovion's Lunestra.

Two phase III trials of the orexin receptor antagonist suvorexant have been completed and the company said they show positive results.

"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," said Peter Kim, president, Merck Research Laboratories.

"We are enthusiastic about the potential of this investigational medicine, and look forward to sharing the results from these studies with the medical community."

The primary endpoint for the trials was change from baseline in subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep at one and three months.

Merck plans to present data from the studies at medical meetings later this year.

Suvorexant is one of five major US filings the company hopes to make in 2012 and 2013, along with neuromuscular reversal agent Bridion (sugammadex), HPV vaccine V503, osteoporosis treatment odanacatib and atherosclerosis medicine Tredaptive ER.

7th February 2012

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