MK 4305 (Merck Inc.) data from two Phase III trials for Sleep Disorder - 15-Jun-2012

Merck announced detailed data from the two Phase III pivotal trials of MK 4305 (suvorexant) at the SLEEP 2012 annual meeting of the Associated Professional Sleep Societies.In both trials, on all primary subjective measures, patients who took suvorexant fell asleep significantly faster and stayed asleep longer compared to patients taking placebo at one month and three months (p<0.003). On the objective measures, suvorexant also significantly reduced the time it took patients to fall into continuous sleep and decreased the time patients spent awake during the night at one month and three months (primary endpoints), and as early as night one (a secondary endpoint) (p<0.001), except for Month 3 in Trial 2, at which point the difference in time to fall into continuous sleep did not reach statistical significance.Specifically, at three months in Trial 1, patients reported suvorexant reduced the time it took them to fall asleep by 25.7 minutes (vs. 17.3 minutes with placebo) and helped them to sleep 60.3 minutes longer (vs. 40.6 minutes with placebo) compared to before they started taking suvorexant. For the objective measures, patients taking suvorexant entered into continuous sleep 36.0 minutes faster (vs. 26.6 minutes with placebo) and spent less time awake during the night by 47.9 minutes (vs. 25.0 minutes with placebo) compared to before they started taking suvorexant. (All of these differences between suvorexant and placebo were statistically significant.).At three months in Trial 2, patients reported suvorexant reduced the time it took them to fall asleep by 33.7 minutes (vs. 20.5 minutes with placebo) and helped them to sleep 62.8 minutes longer (vs. 37.7 minutes with placebo) compared to before they started taking suvorexant. For the objective measures at three months, suvorexant did not achieve statistical significance on the measure of patients falling into continuous sleep faster than with placebo (-32.2 minutes vs. -28.6 minutes, p=0.265). The objective data showed that patients taking suvorexant spent less time awake during the night by 54.2 minutes (vs. 24.8 minutes with placebo) compared to before they started taking suvorexant. (All of these differences were statistically significant except for the one noted above.). Merck plans to file an NDA at the FDA during 2012.