Eisai and Imbrium Therapeutics announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lemborexant, an investigational insomnia treatment.
The NDA submission was based on data from two phase 3 studies (SUNRISE 1 and SUNRISE 2) that enrolled approximately 2000 patients. In SUNRISE 1, lemborexant achieved its primary and key secondary objectives (change from baseline in both sleep onset and sleep maintenance variables using objective polysomnography) vs placebo and vs zolpidem tartrate extended-release (active comparator) in patients aged ≥55 years with insomnia disorder.
In SUNRISE 2, treatment with lemborexant 5mg and 10mg resulted in a statistically significant improvement in subjective sleep onset latency vs placebo (primary endpoint), as assessed by patient sleep diaries. Both doses of lemborexant also led to a statistically significant improvement in sleep maintenance variables of subjective sleep efficiency and subjective wake after sleep onset vs placebo (key secondary endpoints).
Lemborexant, a dual orexin receptor antagonist, inhibits orexin neurotransmission by binding competitively to orexin receptors 1 and 2. It is thought to regulate sleep and wake by dampening wakefulness without hindering the ability to awaken to external stimuli.
The small molecule compound is also being evaluated in a phase 2 study of patients with irregular sleep-wake rhythm disorder and mild to moderate Alzheimer dementia.
The FDA has set a Prescription Drug User Fee Act (PDUFA) date for December 27, 2019.
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