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Eisai and Purdue Pharma Report Results of Studies of Lemborexant in Patients With Sleep Disorder.

M2 PHARMA-March 12, 2018-Eisai and Purdue Pharma Report Results of Studies of Lemborexant in Patients With Sleep Disorder


- Tokyo, Japan-based global research and development-based pharmaceutical company Eisai Co., Ltd. and Stamford, Connecticut-based pharmaceutical company Purdue Pharma L.P. have released positive topline results from multiple studies of lemborexant, an investigational agent for sleep and wake regulation, currently being studied for the treatment of multiple sleep disorders, the companies said.

The Phase 3 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.

This was the first-ever Phase 3 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.

In addition, a Phase 1 safety study assessed the ability to maintain postural stability, awaken to an auditory stimulus, and perform on tests of memory and attention in the middle of the night; the postural stability and tests of memory and attention were repeated in the morning shortly after awakening. The study also measured how quickly participants could return to sleep after being awakened.

The study met its primary endpoint demonstrating that postural stability was clinically meaningfully worse for zolpidem ER 6.25 mg as compared with both treatment arms of lemborexant (5 mg and 10 mg), in healthy volunteers 55 years and older. The only AE observed in two or more people in the lemborexant arms was headache.

A recently completed Phase 1 study that evaluated residual next morning effects via an on-road driving test also achieved its primary objective. This study was conducted versus placebo, with zopiclone included as a positive control, to evaluate potential next morning impairment by measuring adult and elderly participants' driving performance.The most common AEs observed in the lemborexant arms were somnolence and headache.

Lemborexant, a dual orexin receptor antagonist small molecule compound that inhibits orexin neurotransmission by binding competitively to the two subtypes of orexin receptors (orexin receptor 1 and 2, acts on the orexin neurotransmitter system and is believed to regulate sleep and wake by dampening wakefulness without impeding the ability to awaken to external stimuli. Discovered by Eisai, lemborexant is being jointly developed by Eisai and Purdue.

Eisai has over 10,000 employees working across its global network of R and D facilities, manufacturing sites, and marketing subsidiaries.The company strives to deliver innovative products in various therapeutic areas with high unmet medical needs, including neurology and oncology.

Privately-held Purdue Pharma is part of a network of independent associated companies dedicated to providing patients and providers with innovative medicines.

The company's leadership and employees are committed to serving healthcare professionals, patients and caregivers by providing quality products and educational resources.

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Publication:M2 Pharma
Article Type:Clinical report
Date:Mar 12, 2018
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