Phase III pivotal study SUNRISE 1 of E 2006 meets primary endpoint in multiple sleep disorders.- Eisai + Purdue Pharma.

Eisai Co. and Purdue Pharma announced positive topline results from multiple studies of E 2006 (lemborexant), for sleep and wake regulation currently being studied for the treatment of multiple sleep disorders. The Phase III pivotal study, SUNRISE 1, achieved its primary and key secondary objectives versus placebo and versus an active comparator (zolpidem tartrate extended release, "zolpidem ER") in patients 55 years and older with difficulty staying asleep through the night.

With a robust polysomnography (PSG) data set, this was the first-ever Phase III study with pre-specified endpoints versus zolpidem ER, measuring the change from baseline in both sleep onset and sleep maintenance variables, including the time spent awake in the second half of the night, which is a common complaint, especially in the elderly. The study used objective PSG to determine if 5 mg and 10 mg lemborexant were superior to zolpidem ER 6.25 mg and to placebo.

In this study, lemborexant had rates of discontinuation due to adverse events (AEs) comparable to placebo, with the most common AEs in the lemborexant arms being headache and somnolence. Eisai and Purdue plan to present full results of SUNRISE 1 at an upcoming medical meeting in 2018.