Merck prepares insomnia candidate
pharmafile | February 7, 2012 | News story | Sales and Marketing | Merck, insomnia
Merck is to file its new insomnia drug suvorexant, with US regulators later this year.
Suvorexant is an orexin receptor antagonist, which Merck says offers a new way of tackling sleep disorders.
Merck says results in two phase III efficacy trials have been positive, and a New Drug Application will be forthcoming to the FDA – one of the five big US filings Merck anticipates for 2012 and 2013.
Both randomised, double-blind, placebo-controlled studies evaluated suvorexant compared to placebo in adults.
Primary endpoint was change from baseline in subjective total sleep time and time to sleep onset, waking time after persistent sleep onset, and latency to onset of persistent sleep at one and three months.
“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 of 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,” he concluded.
Merck says it will submit the data for presentation at major medical meetings later this year.
If approved, suvorexant would enter a market which analyst Datamonitor has predicted could reach $7.7 billion in 2016.
Competition would come from established brands such as Sanofi’s Stilnoct, Sepracor’s Lunesta, Takeda’s Rozerem and Pfizer’s Indiplon.
Last month Actelion and GlaxoSmithKline admitted they were to abandon development of their phase III insomnia drug almorexant because of problems with side-effects.
Adam Hill
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