New Drug Application Filed for Lemborexant for Insomnia


A new drug application (NDA) has been filed with the Food and Drug Administration (FDA) for lemborexant (Eisei, Woodcliff Lake, NJ and Purdue Pharma, Stamford, CT). Lemborexant is a small molecule under investigation for treatment of the sleep-wake disorder insomnia. Data from clinical trials has shown that people who take lemborexant fall asleep more easily, but also wake without difficulty in reponse to stimuli, and then are able to return to sleep. 

Submission of the NDA was based on results from 2 pivotal trials that enrolled approximately 2,000 patients, the SUNRISE 1 (NCT02783729) and SUNRISE 2 (NCT02952820) trials as well as important safety studies. In the double-blind, placebo-controlled SUNRISE 1 trial, efficacy and safety of lemborexant was compared in a head-to-head manner with zolpidem extended release. Polysomnography was used toobjectively assess sleep parameters of time-to-sleep onset, sleep efficiency, and wake after sleep onset. In SUNRISE 2, patients ability to fall asleep and stay asleep after taking lemborexant or placebo was assessed via patient self-report (sleep diary) over a 12-month period. 

Unlike other treatment for insomnia, lemborexant, which acts on the orexin neurotransmitter system, is believed to act by dampening wakefulness A Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder and mild to moderate Alzheimer's dementia is also underway.


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