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Monday, 2 July 2018, 15:36 HKT/SGT
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Source: Eisai
Eisai to Give Oral Presentation on Results of Phase III Head-to-Head Clinical Study of Lemborexant in Insomnia Disorder
At 43rd Annual Meeting of The Japan Society of Sleep Research

At "Drug Discovery Research For Sleep Medicine" Symposium

TOKYO, July 2, 2018 - (JCN Newswire) - Eisai Co., Ltd. today announced that the latest data from a Phase III clinical study (SUNRISE 1) on its investigational sleep-wake regulation agent lemborexant (development code: E2006), will be presented in an oral presentation at the 43rd Annual Meeting of the Japan Society of Sleep Research being held from July 11 to 13 in Sapporo, Japan. This presentation will be given at the symposium "Drug Discovery Research for Sleep Medicine".

The symposium will report on the latest data on lemborexant from non-clinical research and clinical studies relating to insomnia, including the results of SUNRISE 1. In addition to SUNRISE 1 in which the primary and key secondary objectives were achieved, non-clinical research data from the course of discovery of lemborexant, including medicinal chemistry and pharmacology, will also be highlighted at the symposium.

With a robust polysomnography (PSG) data set, SUNRISE 1 was a Phase III clinical study of the efficacy and safety of lemborexant versus placebo and an active comparator (zolpidem tartrate extended release, "zolpidem ER") in approximately 1,000 patients 55 years and older with insomnia disorder. The study evaluated change from baseline for both sleep onset (primary objective) and sleep maintenance variables (secondary objectives), including the time spent awake in the second half of the night, which is a common complaint, especially in older patients. The study used objective PSG to determine if 5 mg and 10 mg reduced time to sleep onset and prolonged sleep maintenance compared 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.

Discovered by Eisai, lemborexant is being jointly developed by Eisai and Purdue Pharma L.P.

Lemborexant appears to impact an underlying reason for a patient's inability to sleep and wake well. Lemborexant 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.

Through research and development on lemborexant, Eisai and Purdue are striving to bring to patients with sleep-wake disorders a new treatment option for sleep-wake regulation that improves their ability to fall asleep and stay asleep, without impairing them the next morning.


About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.

Furthermore, we invest and participate in several partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit www.eisai.com

Contact:
Public Relations Department, 
Eisai Co., Ltd. 
+81-(0)3-3817-5120


July 2, 2018 15:36 HKT/SGT
Source: Eisai

Eisai (TSE: 4523)

Topic: Press release summary
Sectors: BioTech
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