Jul 06, 2020 09:33 JST
Eisai to Launch In-House Developed New Anti-insomnia Drug Dayvigo (Lemborexant) with Indication for Insomnia in Japan
TOKYO, Jul 06, 2020 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has launched its in-house-discovered and developed orexin receptor antagonist DAYVIGO? 2.5 mg, 5 mg, 10 mg tablets (lemborexant) for treatment of insomnia in Japan on July 6, 2020. Eisai received marketing and manufacturing approval for this formulation on January 23, 2020, and the product was added to Japan?s National health Insurance drug price list on April 22, 2020.
DAYVIGO is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating sleep-wake rhythm by binding competitively to the two subtypes of orexin receptors (OX1R and OX2R). DAYVIGO acts on the orexin neurotransmitter system and is believed to facilitate sleep onset, sleep maintenance, and wake by regulating sleep-wake rhythm.
The approval of DAYVIGO in Japan is based on findings from two pivotal Phase III studies(1),(2) (SUNRISE 1 and SUNRISE 2) in adult patients with insomnia, as well as evaluation of residual effects including the middle of the night waking, next morning postural stability (falling prediction indicator), and memory through Studies 1063 and 1084.
The SUNRISE 11 clinical trial conducted in North America and Europe utilized objective assessment with overnight measurement through polysomnography, and confirmed statistically significant shortening or improvement of sleep onset latency (primary objective) as well as sleep efficiency and wake after sleep onset (secondary objectives) with DAYVIGO compared to tartrate-sustained-release drug zolpidem (6.25 mg, not yet approved in Japan) and placebo.
The SUNRISE 22 clinical trial, conducted globally including in Japan, evaluated patients subjectively through sleep diaries and confirmed statistically significant improvement in sleep onset latency (primary objective) as well as subjective sleep efficiency and subjective wake after sleep onset (secondary objectives) compared to placebo. Main side effects of DAYVIGO as observed in the two trials were somnolence, headache, dizziness, and fatigue.
Analyses in both studies suggested DAYVIGO was not associated with rebound insomnia, and there was no evidence of withdrawal effects following treatment discontinuation, suggesting it does not produce physical dependence in those taking it for up to one year.
In a special safety study (Study 106)(3), DAYVIGO at 5 mg and 10 mg doses did not cause statistically significant impairment in the next morning driving performance in healthy adult or elderly subjects (compared with placebo). Additional special safety studies (Study 108)(4) evaluated middle-of-the-night safety, next morning postural stability, and memory. The effects of DAYVIGO on next day postural stability and memory were evaluated in two randomized, placebo and active-controlled trials. There were no meaningful differences between DAYVIGO and placebo on next-day postural stability or memory at either dose. While there is a need for caution regarding the potential for middle-of-the-night postural instability as well as attention and memory impairment, no problem-signifying degradation was observed between DAYVIGO- and placebo-administered groups.
In June 2020, DAYVIGO was launched in the U.S. for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. In addition, Eisai submitted a new drug application seeking approval of DAYVIGO in Canada and Australia.
Insomnia is characterized by difficulty falling asleep, staying asleep, or both, despite an adequate opportunity to sleep, which can lead to daytime consequences, such as fatigue, difficulty concentrating, and irritability.(5),(6) Insomnia is one of the most common sleep-wake disorders. Approximately 30% of adults worldwide have symptoms of insomnia.(7),(8) In particular, older adults tend to have a higher prevalence rate with many experiencing insomnia symptoms for months to years. As a result, insomnia causes various social losses, such as long absences and reduced productivity. It can increase the risk of falling in older adults.(9)
Through the launch of DAYVIGO, Eisai will continue to prioritize the provision of appropriate usage and safety information. By providing DAYVIGO as a new option for the treatment of insomnia, Eisai aims for contribution to the restoration of daytime function and recovery for patients with insomnia by delivering an active daytime life through fast sleep onset and good quality sleep.
For more information visit https://www.eisai.com/news/2020/pdf/enews202036pdf.pdf.
Eisai Co., Ltd. defines 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 to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. As a global pharmaceutical company, our mission extends to patients around the world through working with key stakeholders to improve access to medicines in developing and emerging countries.
For more information about Eisai Co., Ltd., please visit https://www.eisai.com
Public Relations Department
Eisai Co., Ltd.
Sectors: BioTech, HealthCare
Copyright ©2020 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
More Latest Release >>
Mitsubishi Corporation Releases Financial Results for the Three Months Ended June 2020
Aug 13, 2020 15:33 JST
NEC and PERSOL CAREER Start PoC of Recruitment Service for International IT Engineers using Blockchain Technology
Aug 13, 2020 09:57 JST
Hitachi and Bombardier Awarded Contract to Supply 23 Very High-speed Frecciarossa Trains to Trenitalia for Operation by ILSA on Routes in Spain
Aug 12, 2020 17:56 JST
Hitachi Rail to Acquire Railway Technology Firm Perpetuum to Accelerate UK Digitization Strategy
Aug 12, 2020 17:33 JST
SDK Revises Forecast of Consolidated Performance for Full-year 2020
Aug 12, 2020 16:00 JST
Showa Denko Announces 2020 2Q Consolidated Financial Results
Aug 12, 2020 16:00 JST
Banqsoft Acquires Concent to Expand and Broaden its Market Position
Aug 12, 2020 09:18 JST
Mitsubishi Corporation: Commercial Operations Commence at Cameron LNG
Aug 11, 2020 09:07 JST
TOYOTA GAZOO Racing Back on Track at SPA
Aug 07, 2020 18:04 JST
Leveraging EV/PHEV as Resources for Virtual Power Plants Commencement of Trial Operation of V2G Business Demonstration Facilities
Aug 07, 2020 09:03 JST
SDK to Record Operating/Non-operating Expenses for Acquisition of Hitachi Chemical's Shares, and Extraordinary Loss
Aug 06, 2020 16:00 JST
Mitsubishi Corporation: Trials of "KnowRoute", AI-Controlled On-Demand Bus Service to Commence in Shiojiri City, Nagano Prefecture
Aug 06, 2020 13:36 JST
Honda's Consolidated Financial Summary for the Fiscal Q1 Ended June 30, 2020 and Forecasts for the FY Ending March 31, 2021
Aug 05, 2020 18:45 JST
DENSO Establishes Pittsburgh Innovation Lab to Accelerate Automated Driving R&D
Aug 05, 2020 16:09 JST
Fujitsu Enhances VPS Series to Drive DX for Production Preparation Tasks
Aug 05, 2020 12:30 JST
Mitsubishi Corporation: R&D on Use of CO2 in Concrete
Aug 05, 2020 11:13 JST
MHPS Receives Contract for AQCS Equipment for a Chemical Plant in Poland
Aug 04, 2020 15:19 JST
MHI Machine Tool Develops "FR Series" of Machines to Manufacture Gears for Robots
Aug 04, 2020 12:10 JST
MHPS to Change Company Name to "Mitsubishi Power"
Jul 31, 2020 16:02 JST
DENSO Announces First Quarter Financial Results
Jul 31, 2020 14:11 JST