May 29, 2019 10:05 JST

Source: Eisai

Eisai to Present Latest Data on Lemborexant including Integrated Analysis of Phase III Clinical Studies at 33rd Annual Sleep Meeting

Tokyo, May 29, 2019 - (JCN Newswire) - Eisai Co.,Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") today announced that latest information on lemborexant, an investigational sleep-wake regulation agent being studied for the treatment of multiple sleepwake disorders, including insomnia and Irregular Sleep-Wake Rhythm Disorder (ISWRD) will be presented at the 33rd Annual Meeting of the Associated Professional Sleep Societies (SLEEP 2019), from June 8 to 12 in San Antonio, Texas, the United States.

Eight posters including the integrated analysis of lemborexant's effects on daily function and disease severity as well as sleep onset and sleep maintenance for the combined 1,955 patient population of two pivotal clinical Phase III studies, SUNRISE 1 (Study 304) and SUNRISE 2 (Study 303) in insomnia disorders, and an evaluation of results on respiratory function after administration of lemborexant in elderly and mild obstructive sleep apnea, and the latest pre-clinical data on ISWRD will be presented.

Lemborexant acts on the orexin neurotransmitter system and is believed to regulate sleep and wake by controlling arousal without affecting awakening by external stimuli, and is being developed for the treatment of multiple sleep-wake disorders including insomnia disorder. In December 2018 and March 2019, new drug applications seeking approval of lemborexant for use in the treatment of insomnia disorder were submitted in the United States and Japan, respectively. For the ongoing clinical studies, please visit clinicaltrials.gov.

Through the development of lemborexant, Eisai is aiming to bring to patients suffering from sleep-wake disorders a new treatment option to improve their ability to fall and stay asleep and wake without impairing the next morning, and is striving to further contribute to satisfying unmet medical needs and improve the benefits to patients and their families.

  • Presentations for Lemborexant:
    Poster session: P18, Presentation date: Monday June 10, 5:15pm - 7:15pm (local time)
  Presentation Title
Poster Number: 102
Abstract: 0367
Lemborexant Treatment for Insomnia: Six-month Safety
Poster Number: 105
Abstract: 0368
Efficacy and Tolerability of Lemborexant in Female and Male Subjects With Insomnia
Poster Number: 106
Abstract: 0369
Effect of Lemborexant on Sleep Architecture in Older Adults With Insomnia Disorder
Poster Number: 107
Abstract: 0370
Patient-Reported Sleep Onset and Sleep Maintenance: Pooled Analyses of Lemborexant Phase 3 Studies
Poster Number: 108
Abstract: 0371
Lemborexant Treatment for Insomnia in Phase 3: Impact on Disease Severity
Poster Number: 103
Abstract: 0429
Respiratory Safety of Lemborexant in Adult and Elderly Subjects With Mild Obstructive Sleep Apnea
Poster Number: 104
Abstract: 0430
Respiratory Safety of Lemborexant in Healthy Adult and Elderly Subjects
Poster Number: 022
Abstract: 0056
SAMP8 Mice as a Preclinical Model for Irregular Sleep-Wake Rhythm Disorder and Efficacy of the Dual Orexin (Hypocretin) Receptor Antagonist Lemborexant


Separate from the poster presentations, Eisai will host a symposium, an interactive dialogue on insomnia diagnostic and therapeutic decision making, which will be held on Sunday, June 9, from 6:15pm – 8:30pm (local time).

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

Source: Eisai
Sectors: BioTech

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