Lemborexant

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

Retrieved on: 
Thursday, September 19, 2019
Chemical compounds, Psychoactive drugs, RTT, Psychiatric diagnosis, Psychiatry, Cognitive disorders, Learning disabilities, Hypnotics, Lemborexant, Insomnia, Dementia, Alzheimer's disease

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

Retrieved on: 
Tuesday, June 11, 2019
Chemical compounds, Branches of biology, Sleep disorders, Animal physiology, Hypnotics, Cyclopropanes, Lemborexant, Pyridines, Pyrimidines, Sleep apnea, Obstructive sleep apnea, Apnea

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.

Extensive Analyses of Phase 3 Data for Investigational Lemborexant Assess Efficacy and Safety Profile for the Potential Treatment of Insomnia in Adults

Retrieved on: 
Tuesday, June 11, 2019
Chemical compounds, Hypnotics, Organofluorides, Cyclopropanes, Lemborexant, Pyridines, Pyrimidines

These analyses of lemborexant assessed its efficacy on key insomnia measures, improvement in patient daytime function and long-term safety.

Key Points: 
  • These analyses of lemborexant assessed its efficacy on key insomnia measures, improvement in patient daytime function and long-term safety.
  • Earlier this year, the U.S. Food and Drug Administration accepted for review the New Drug Application for lemborexant for the treatment of insomnia.
  • Serious TEAEs were observed in a small proportion of patients (2.2% with lemborexant 5 mg, 2.9% with lemborexant 10 mg, 1.6% with placebo).
  • Efficacy analyses included 402 (23.7%) male and 1,291 (76.3%) female patients, and safety analyses included 404 (25.0%) male and 1,286 (75.0%) female patients.

Eisai to Present Eight Lemborexant Posters at SLEEP 2019 Meeting, Including New Pooled Analyses From Phase 3 Studies and New Phase 1 Data

Retrieved on: 
Tuesday, May 28, 2019
Chemical compounds, Psychoactive drugs, Hypnotics, Cyclopropanes, Lemborexant, Organofluorides, Pyridines, Pyrimidines, Insomnia, Eisai, Sleep disorder

Separate from the poster presentations, Eisai will host a symposium entitled An Interactive Case-Based Dialogue on Insomnia Diagnostic and Therapeutic Decision Making.

Key Points: 
  • Separate from the poster presentations, Eisai will host a symposium entitled An Interactive Case-Based Dialogue on Insomnia Diagnostic and Therapeutic Decision Making.
  • 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.
  • Eisai is investigating lemborexant as a potential treatment option for multiple sleep-wake disorders, such as insomnia.

New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States

Retrieved on: 
Tuesday, January 15, 2019
Hypnotics, Chemistry, Organic chemistry, Organofluorides, Neurochemistry, RTT, GABAA receptor positive allosteric modulators, Pyrimidines, Lemborexant, Zolpidem, SB-649868

In addition to the treatment of insomnia disorder, a Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder and mild to moderate Alzheimer's dementia is underway.

Key Points: 
  • In addition to the treatment of insomnia disorder, a Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder and mild to moderate Alzheimer's dementia is underway.
  • In this study, patients were randomized to receive placebo or one of three treatment regimens (lemborexant 5 mg, lemborexant 10 mg, zolpidem ER 6.25 mg).
  • During the active-only treatment period, patients who received placebo during the first period were re-randomized to receive lemborexant 5 mg or 10 mg.
  • Patients who received active treatment during the first period continued on the treatment to which they were originally randomized.

Eisai To Present Latest Data On Alzheimer's Disease / Dementia Pipeline At The 11th Clinical Trials On Alzheimer's Disease (CTAD) Conference

Retrieved on: 
Thursday, October 18, 2018
Medicine, Chemistry, Health, Monoclonal antibodies, Cognitive disorders, Learning disabilities, Psychiatric diagnosis, Alzheimer's disease research, Aducanumab, Lemborexant, Biogen, Eisai

Data will also be presented on lemborexant, an investigational compound that is being jointly developed by Eisai and Purdue Pharma.

Key Points: 
  • Data will also be presented on lemborexant, an investigational compound that is being jointly developed by Eisai and Purdue Pharma.
  • Eisai and Biogen previously announced results from BAN2401 Study 201 during the Alzheimer's Association International Conference (AAIC) in July.
  • Elenbecestat is currently being investigated in two ongoing Phase 3 clinical studies, MISSION AD1/2 in patients with early Alzheimer's disease.
  • Elenbecestat in MCI-to-Moderate Alzheimer's Disease: Safety and Effectiveness as Measured by Amyloid PET and the ADCOMS Clinical Endpoints
    What have we Learned from Aducanumab?

Eisai and Purdue Pharma Announce Key Phase 1 Clinical Studies of Lemborexant to be Presented at the 32nd Annual SLEEP Meeting

Retrieved on: 
Tuesday, May 22, 2018
Neuroscience, Biology, Chemistry, Cyclopropanes, Hypnotics, Lemborexant, Organofluorides, Pyridines, Pyrimidines, Eisai, Sleep

"It is important that a treatment for sleep/wake regulation allows a patient to not only sleep well, but also wake well.

Key Points: 
  • "It is important that a treatment for sleep/wake regulation allows a patient to not only sleep well, but also wake well.
  • "These studies provide important information about how lemborexant affects the ability to awaken after sleep."
  • The following data will be presented by Eisai and Purdue Pharma at SLEEP 2018:
    Discovered by Eisai, lemborexant an investigational sleep/wake regulation agent is being jointly developed by Eisai and Purdue Pharma.
  • Therefore, Eisai and Purdue have been developing and studying lemborexant as a potential treatment for multiple sleep disorders.