Eisai Co Ltd will present 8 poster presentations on lemborexant, an investigational agent being studied for the treatment of insomnia, at SLEEP 2019.
Long-term safety data from SUNRISE 2 (Study 303), sleep architecture data from SUNRISE 1 (Study 304), and pooled analyses from these two Phase 3 studies with a combined adult and elderly insomnia disorder population totaling over 1,600 patients will be presented, reporting on the impact of lemborexant treatment on daily function, disease severity, sleep onset, and sleep maintenance. Findings from these analyses reveal insights and will be presented in the following posters:
- Poster 102/Abstract 0367: Lemborexant Treatment for Insomnia: Six-month Safety
- Poster 105/Abstract 0368: Efficacy and Tolerability of Lemborexant in Female and Male Subjects With Insomnia
- Poster 106/Abstract 0369: Effect of Lemborexant on Sleep Architecture in Older Adults With Insomnia Disorder
- Poster 107/Abstract 0370: Patient-Reported Sleep Onset and Sleep Maintenance: Pooled Analyses of Lemborexant Phase 3 Studies
- Poster 108/Abstract 0371: Lemborexant Treatment for Insomnia in Phase 3: Impact on Disease Severity
“Eisai strives to help people who experience insomnia fall asleep, stay asleep, and wake ready the next morning,” says Ivan Cheung, chairman and CEO of Eisai Inc, in a release. “Our work to develop lemborexant is one more way in which Eisai is breaking through to provide innovative solutions to patients whose current medical needs are not being met.”
Additionally, Eisai will present Phase 1 study results evaluating respiratory function following lemborexant administration, as respiratory safety is a concern in the treatment of insomnia.1 Presentations on this topic include:
- Poster 103/Abstract 0429: Respiratory Safety of Lemborexant in Adult and Elderly Subjects With Mild Obstructive Sleep Apnea
- Poster 104/Abstract 0430: Respiratory Safety of Lemborexant in Healthy Adult and Elderly Subjects
Lemborexant is also being studied as a potential treatment of ISWRD in patients with Alzheimer’s disease. The following poster with data from a preclinical model of ISWRD will also be presented:
- Poster 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
All data will be presented during the P-18 poster session on Monday, June 10, 5:15 – 7:15 pm CT.
Separate from the poster presentations, Eisai will host a symposium entitled An Interactive Case-Based Dialogue on Insomnia Diagnostic and Therapeutic Decision Making. This symposium will be chaired by Phyllis Zee, MD, PhD, professor of neurology, Northwestern University and Director, Sleep Disorders Center at Northwestern Memorial Hospital, and will feature other esteemed faculty:
- Sonia Ancoli-Israel, PhD, emeritus professor of psychiatry and medicine and professor of research, University of California San Diego School of Medicine
- Daniel Buysse, MD, professor of sleep medicine, professor of psychiatry and clinical and translational science, University of Pittsburgh School of Medicine
- David Neubauer, MD, associate professor, Johns Hopkins School of Medicine, Faculty, Johns Hopkins Sleep Disorders Center
The symposium is open to all attendees of the conference. There is no need to pre-register; your conference badge allows you to attend the symposium.
Earlier this year, the Food and Drug Administration accepted for review the New Drug Application for lemborexant for the treatment of insomnia. A target Prescription Drug User Fee Act date is set for December 27, 2019.
This news brief 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.