Dec 23, 2019: Eisai Co. announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application for its in-house discovered and developed orexin receptor antagonist DAYVIGOTM (lemborexant) for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults.
It will commercially available in 5 mg and 10 mg tablets following scheduling by the U.S. Drug Enforcement Administration (DEA).
Lemborexant is characterized by difficulties with sleep onset and/or sleep maintenance is supposed to be through antagonism of orexin receptors.
The orexin neuropeptide signaling system plays an important role in wakefulness.Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to orexin receptors OX1R and OX2R is reflection to restrain wake drive.
This approval was based on the results of a clinical development program that incorporated two pivotal Phase III studies (SUNRISE 2 and SUNRISE 1), which evaluated DAYVIGO versus comparators for up to one month and DAYVIGO versus placebo for six-months, respectively, in a totality of about 2,000 adult patients with insomnia. https://www.eisai.com/news/2019/news201993.html