Lemborexant

Eisai To Present Latest Data of Lemborexant at 35th Annual Sleep Meeting (SLEEP2021)

Wednesday, June 9, 2021 - 3:31am

TOKYO, June 9, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that a total of 5 poster presentations including the latest data on its in-house discovered orexin receptor antagonist lemborexant (product name: DAYVIGO) will be given at the 35th annual meeting of the Associated Professional Sleep Societies (SLEEP 2021), to be held virtually from June 10 to 13, 2021.

Key Points: 
  • TOKYO, June 9, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that a total of 5 poster presentations including the latest data on its in-house discovered orexin receptor antagonist lemborexant (product name: DAYVIGO) will be given at the 35th annual meeting of the Associated Professional Sleep Societies (SLEEP 2021), to be held virtually from June 10 to 13, 2021.
  • Major poster presentations include the results of a study evaluating next-dose transition from zolpidem to lemborexant for insomnia treatment (Poster Numbers: #335 and #337).
  • Eisai considers neurology a therapeutic area of focus.
  • Eisai strives to create innovative products in therapeutic areas with high unmet medical needs as soon as possible, and will further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, those living with neurological diseases and their families.

Eisai to Present Latest Data of Lemborexant at 34th Annual Sleep Meeting (SLEEP2020)

Tuesday, August 25, 2020 - 2:30am

Lemborexant acts on the orexin neurotransmitter system and is believed to facilitate sleep onset, sleep maintenance, and wake by regulating sleep-wake rhythms.

Key Points: 
  • Lemborexant acts on the orexin neurotransmitter system and is believed to facilitate sleep onset, sleep maintenance, and wake by regulating sleep-wake rhythms.
  • Lemborexant was approved in the U.S. for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance, and was approved in Japan for the treatment of insomnia.
  • The clinical development of lemborexant in patients with Irregular Sleep Wake Rhythm Disorder (ISWRD) associated with mild-to-moderate Alzheimer's dementia is ongoing.
  • (3),(4) In particular, older adults tend to have a higher prevalence rate with many experiencing insomnia symptoms for months to years.

Eisai to Present Latest Insomnia Research, Including Data on New Treatment DAYVIGO™ (lemborexant) CIV, at the SLEEP 2020 Virtual Conference

Monday, August 24, 2020 - 1:10pm

Additional research to be presented will explore sleep onset and sleep maintenance responder profiles over 12 months of treatment with DAYVIGO, efficacy and safety of DAYVIGO in females of perimenopausal age with insomnia disorder, and impact of DAYVIGO treatment on fatigue severity.

Key Points: 
  • Additional research to be presented will explore sleep onset and sleep maintenance responder profiles over 12 months of treatment with DAYVIGO, efficacy and safety of DAYVIGO in females of perimenopausal age with insomnia disorder, and impact of DAYVIGO treatment on fatigue severity.
  • In addition, interim results from a multi-center pilot study evaluating the next-dose transition from zolpidem to DAYVIGO for the treatment of insomnia will be presented.
  • DAYVIGO (lemborexant) is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
  • CNS depressant effects may persist in some patients up to several days after discontinuing DAYVIGO.

Eisai to Present Latest Data on Pipeline Assets in the Area of Alzheimer's Disease and Dementia at the Alzheimer's Association International Conference (AAIC) 2020

Wednesday, July 22, 2020 - 9:04am

Regarding BAN2401, the clinical study design of the newly initiated Phase III clinical study AHEAD 3-45 for preclinical Alzheimer's disease (AD) patients will be presented orally.

Key Points: 
  • Regarding BAN2401, the clinical study design of the newly initiated Phase III clinical study AHEAD 3-45 for preclinical Alzheimer's disease (AD) patients will be presented orally.
  • The safety and efficacy results from a Phase II clinical study on lemborexant (orexin receptor antagonist) targeting Irregular Sleep Wake Rhythm Disorder (ISWRD) associated with AD will be presented.
  • Finally, they will hold a discussion on the future outlook of this classification system for Alzheimer's pharmacological trials and clinical practice.
  • For more information about Eisai Co., Ltd., please visit https://www.eisai.com
    Copyright 2020 JCN Newswire .

Eisai to Launch In-House Developed New Anti-insomnia Drug Dayvigo (Lemborexant) with Indication for Insomnia in Japan

Monday, July 6, 2020 - 1:33am

2.5 mg, 5 mg, 10 mg tablets (lemborexant) for treatment of insomnia in Japan on July 6, 2020.

Key Points: 
  • 2.5 mg, 5 mg, 10 mg tablets (lemborexant) for treatment of insomnia in Japan on July 6, 2020.
  • DAYVIGO acts on the orexin neurotransmitter system and is believed to facilitate sleep onset, sleep maintenance, and wake by regulating sleep-wake rhythm.
  • (9)
    Through the launch of DAYVIGO, Eisai will continue to prioritize the provision of appropriate usage and safety information.
  • For more information about Eisai Co., Ltd., please visit https://www.eisai.com
    Public Relations Department Eisai Co., Ltd. +81-(0)3-3817-5120
    Copyright 2020 JCN Newswire .

Eisai Announces U.S. Availability of DAYVIGO® (lemborexant) CIV, a New Treatment Option for Adults With Insomnia

Monday, June 1, 2020 - 1:05pm

"DAYVIGO may be an appropriate treatment option for some of these patients."

Key Points: 
  • "DAYVIGO may be an appropriate treatment option for some of these patients."
  • "DAYVIGO is the first FDA-approved insomnia medication with safety data over a 12-month treatment period and with sleep onset and sleep maintenance efficacy data over a six-month treatment period in a pivotal clinical study.
  • Eisai remains committed to discovering and developing innovative solutions to unmet medical needs that benefit patients and their families."
  • DAYVIGO (lemborexant) is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

U.S. FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients

Monday, December 23, 2019 - 1:05pm

Patients were randomized to placebo (n=325), DAYVIGO 5 mg (n=323), or DAYVIGO 10 mg (n=323) once nightly.

Key Points: 
  • Patients were randomized to placebo (n=325), DAYVIGO 5 mg (n=323), or DAYVIGO 10 mg (n=323) once nightly.
  • Patients were randomized to placebo (n=208), DAYVIGO 5 mg (n=266) or 10 mg (n=269), or active comparator (n=263) once nightly.
  • DAYVIGO (lemborexant) is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
  • Patients with Compromised Respiratory Function:
    The effect of DAYVIGO on respiratory function should be considered for patients with compromised respiratory function.

Three New Analyses of Data Expand Understanding of the Potential Role for Investigational Agent Lemborexant in Insomnia and Irregular Sleep-Wake Rhythm Disorder

Friday, September 27, 2019 - 6:24pm

Active-only treatment period data for patients who received lemborexant in the first six months was presented at 2019 World Sleep Congress.

Key Points: 
  • Active-only treatment period data for patients who received lemborexant in the first six months was presented at 2019 World Sleep Congress.
  • Lemborexant 10 mg resulted in mean increases in sSE from baseline of 15.6% at six months and 17.6% at 12 months.
  • Lemborexant 10 mg resulted in mean reductions from baseline of 48.1 minutes at six months and 56.8 minutes at 12 months.
  • A small proportion of patients discontinued the study due to a TEAE (lemborexant 5 mg, 1.6%; lemborexant 10 mg, 1.8%).

Eisai to Present New 12-month Safety & Effectiveness Data from Phase 3 Lemborexant SUNRISE 2 Study and New Patient and Cohabitant Insights about Insomnia and Toll on Next-Day Functioning at World Sleep Congress

Thursday, September 19, 2019 - 5:35pm

Earlier this year, the U.S. Food and Drug Administration accepted for review the New Drug Application for lemborexant for the treatment of insomnia.

Key Points: 
  • Earlier this year, the U.S. Food and Drug Administration accepted for review the New Drug Application for lemborexant for the treatment of insomnia.
  • This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety.
  • There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.
  • Additionally, a Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder and mild to moderate Alzheimer's dementia is underway.

Lemborexant Respiratory Safety Data Presented at SLEEP 2019

Tuesday, June 11, 2019 - 4:00pm

WOODCLIFF LAKE, N.J., June 11, 2019 /PRNewswire/ --Eisai Inc. today announced data on the respiratory safety of investigational lemborexant with multiple and single dosing in healthy adult and elderly individuals, as well as in those with mild obstructive sleep apnea (OSA).

Key Points: 
  • WOODCLIFF LAKE, N.J., June 11, 2019 /PRNewswire/ --Eisai Inc. today announced data on the respiratory safety of investigational lemborexant with multiple and single dosing in healthy adult and elderly individuals, as well as in those with mild obstructive sleep apnea (OSA).
  • These studies were presented at the 33rd annual meeting of the Associated Professional Sleep Societies (SLEEP 2019) in San Antonio.
  • Key respiratory safety data presented at SLEEP 2019 are from Study 102, a two-part study on the respiratory safety of lemborexant.
  • The incidence of TEAEs reported was 6.3% with lemborexant 10 mg, 23.5% with lemborexant 25 mg and 6.3% with placebo.