Merck’s sleep aid drug meets goals
pharmafile | June 15, 2012 | News story | Research and Development, Sales and Marketing | FDA, Merck, insomnia, sleep disorder, suvorexant
Merck’s novel insomnia drug suvorexant has improved patients’ ability to fall asleep, according to new data from two Phase III trials.
The manufacturer says this means it is on track to file the orexin receptor antagonist with the FDA later this year: two recent Phase III efficacy programmes were also positive.
The new randomised, double-blind studies evaluated suvorexant compared to placebo in adults: Merck said the first showed patients fell asleep faster (25.7 minutes versus 17.3 minutes with placebo) and stayed asleep longer (60.3 minutes versus 40.6 minutes) compared to before they started taking the drug.
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 patients entered continuous sleep 36 minutes faster (26.6 minutes with placebo) and spent less time awake at night by 47.9 minutes (versus 25.0 minutes).
At three months in trial 2, suvorexant patients took less time to fall asleep (33.7 minutes versus 20.5 minutes) and slept longer (62.8 minutes longer versus 37.7 minutes). The only blot on the findings was that at this point the time to fall into continuous sleep did not reach statistical significance.
“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.
Analysts have given the prospective filing a cautious welcome, citing the drug’s superiority to placebo and the 12 months of safety and efficacy data which may lead to its labelling for chronic use.
While insomnia is a potentially lucrative market (Datamonitor has predicted it could reach $7.7 billion in 2016) it is a competitive one, even though Merck says its brand offers a new way of tackling sleep disorders.
Competition would come from established brands such as Sanofi’s Stilnox/Ambien, Sepracor’s Lunesta, Takeda’s Rozerem and Pfizer’s Indiplon.
“It will be attempting to enter a highly genericised space with a well-established competitor in the form of Sanofi’s Ambien franchise,” warns EP Vantage in a note.
With other alternatives available, doctors and health authorities may therefore want more experience with the drug before authorising it widely.
“This means Merck’s efforts may not yield immediate results, a fact that might disappoint some looking for the New Jersey giant to begin addressing stagnant sales growth,” the analyst concludes.
Adam Hill
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