Head of Merck's new sleep drug class looks promising in IIb

An experimental insomnia drug from Merck produced some promising mid-stage data in comparison to a placebo, which bodes well for an potential therapy which has since moved into Phase III and is slated for a 2012 FDA application.

MK-4305 works by putting the brakes on orexin, a neuropeptide that helps regulate the body's balance of sleep and alertness. By reining in production of orexins, researchers believe they can prevent the brain's arousal system from kicking into gear, helping ensure a good night's sleep.

Four doses were put to the test in the 254-patient Phase IIb clinical trial, with patients in the 40 mg group sleeping 7.9 percent more than the placebo arm. And the experimental medicine helped people fall asleep faster and stay asleep longer than a placebo, addressing two key problems with insomnia. "Forty milligrams looked like best dose on efficacy and tolerability," David Michelson, Merck's vice president for neuroscience clinical research, tells Reuters.

"Phase III research will provide further insight into the safety and efficacy profile of MK-4305, which, if approved, would provide a new class of insomnia treatments," Michelson said in a statement.

- check out Merck's release
- here's the story from Reuters

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