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news.Merck & Co has released results from MK-4305 Phase IIb study which showed that MK-4305, an investigational dual orexin receptor antagonist, was more effective than placebo in improving overall sleep efficiency at night one and at the end of week four in patients with primary insomnia.
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Orexins are neuropeptides (chemical messengers) that are released by specialised neurons in the hypothalamus region of the brain and are believed to be an important regulator of the brain’s sleep-wake process.
Th study was a multicentered, randomised, double-blind, placebo-controlled crossover dose-ranging study designed to evaluate the safety and efficacy of four doses of MK-4305 (10, 20, 40 and 80mg) in patients with primary insomnia.
In the study significant increases from baseline sleep efficiency (SE) versus placebo were observed for all doses of MK-4305 for the co-primary endpoints of SE at night one and at the end of week four.
Significant dose-related effects were also generally observed for sleep induction and maintenance parameters, for most doses and time points. All doses of MK-4305 improved objectively measured sleep maintenance, as evidenced by reductions in the secondary endpoint of baseline-adjusted WASO versus placebo both at night one and at the end of week four.
The data also suggested that MK-4305 was effective in improving sleep onset at other doses but not at both time points, with nominal p-values < 0.05 at night one and at the end of week four.
Merck said that the initial Phase IIb study was not aimed at definitively assessing LPS, as this would have required a markedly larger number of patients than the number required to achieve the sleep efficiency primary endpoint.
David Michelson, VP of Neuroscience Clinical Research at Merck, said: “Since the discovery and characterization of orexin over the past decade as an important component of the sleep-wake system, Merck has been actively committed to discovering and developing potential interventions for sleep disorders that target the orexin receptors. We are encouraged by these phase II results showing positive effects of MK-4305 in patients with primary insomnia.
“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.”