WOODCLIFF LAKE, N.J., Aug. 24, 2020 /PRNewswire/ -- Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced it will present new DAYVIGO™ (lemborexant) CIV research at the SLEEP 2020 virtual conference, the 34th annual meeting of the Associated Professional Sleep Societies, August 27-30, 2020. DAYVIGO, a dual orexin receptor antagonist, was recently launched in the U.S. for the treatment of adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.1
Highlights include an oral presentation focusing on the long-term efficacy and safety of DAYVIGO in adults ages 65 and older with insomnia disorder from the Phase 3 clinical study, SUNRISE 2, in which patients were evaluated for up to 12 months. 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.
"We look forward to sharing new findings about safety and efficacy of DAYVIGO in specific patient populations, particularly those related to its long-term impact in individuals 65 years and older, at SLEEP 2020," said Lynn Kramer, MD, Chief Clinical Officer, Neurology Business Group, Eisai. "These findings will provide key considerations for addressing insomnia in specific patient populations. Insomnia affects millions of people in the United States.2 This research is especially relevant now, as we know life changes due to the COVID-19 pandemic are causing increased sleep problems."3
Eisai's research to be presented at SLEEP 2020 includes:
DAYVIGO (LEMBOREXANT)
"SLEEP 2020 is particularly exciting for Eisai as we recently launched DAYVIGO for adults with insomnia in the U.S. and Japan and are filing for approval in other countries," said Ivan Cheung, Chairman, Eisai Inc. and Global President, Neurology Business Group, Eisai Co., Ltd. "Eisai has created new digital tools including an online sleep tracker and other patient resources to allow us to serve insomnia patients in a more holistic manner."
[Notes to editors]
1. About Lemborexant
Lemborexant is a small-molecule compound, discovered and developed by Eisai in-house scientists, that inhibits orexin signaling by binding competitively to both orexin receptor subtypes (orexin receptor 1 and 2). In individuals with normal daily sleep-wake rhythms, orexin signaling is believed to promote periods of wakefulness.2 In individuals with insomnia, it is possible that orexin signaling regulating wakefulness is not functioning normally.
INDICATION
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.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
DRUG ABUSE AND DEPENDENCE
For more information about DAYVIGO, see full Prescribing Information.
2. About Insomnia
Population studies show that sleep disorders affect many more people worldwide than previously thought.2 Insomnia symptoms affect approximately 30% of the adult population worldwide.4 Insomnia disorder is characterized by difficulty falling asleep, staying asleep or both, despite an adequate opportunity to sleep.5
Diagnostic criteria for insomnia disorder include if the sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral or other important areas of functioning, occurs at least three night per week and is present for at least three months.6
Sleeping well is essential for good health. Studies suggest an optimal sleep duration between seven and eight hours.7
Women are 1.4 times more likely than men to suffer from insomnia.8 Older adults also have a higher prevalence of insomnia; aging is often accompanied by changes in sleep patterns, including disrupted sleep, frequent waking, and early waking, that can lead to less sleep time.9
3. About SUNRISE 2 (Study 1)1
SUNRISE 2: six-month placebo-controlled treatment trial with a 6-month parallel-group extension period including adult patients age 18 or older who met DSM-5 criteria for insomnia disorder. Patients were randomized to placebo (n=325), DAYVIGO 5 mg (n=323), or DAYVIGO 10 mg (n=323) once nightly. The primary efficacy endpoint was the mean change from baseline to end of treatment at six months for subjective sleep onset latency (sSOL; the estimated minutes from the time that the patient attempted to sleep until sleep onset). Secondary efficacy endpoints were mean change from baseline to end of treatment at six months subjective sleep efficiency (sSEF; the proportion of time spent asleep per time in bed) and wake after sleep onset (sWASO; the minutes of wake from the onset of sleep until wake time). These endpoints were measured by sleep diary.
4. About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn.
References
1 Eisai Inc. DAYVIGO Full Prescribing Information. 2019.
2 Ferrie JE, et al. Sleep epidemiology – a rapidly growing field. Int J Epidemiol. 2011;40(6):1431–1437.
3 The Harvard Gazette. Insomnia in a pandemic. April 2020. Retrieved at https://news.harvard.edu/gazette/story/2020/04/sleep-problems-becoming-risk-factor-as-pandemic-continues/.
4 Roth T. Insomnia: definition, prevalence, etiology and consequences. J Clin Sleep Med. 2007;3(5 Suppl):S7–S10.
5 Institute of Medicine. Sleep disorders and sleep deprivation: An unmet public health problem. Washington, DC: National Academies Press. 2006.
6 American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-5. Arlington, VA: American Psychiatric Publishing, 2013.
7 Cappuccio FP, et al. Sleep and cardio-metabolic disease. Curr Cardiol Rep. 2017;19:110.
8 Roth T, et al. Prevalence and perceived health associated with insomnia based on DSM-IV-TR; International Statistical Classification of Diseases and Related Health Problems, tenth revision; and Research Diagnostic Criteria/International Classification of Sleep Disorders, second edition criteria: results from the America Insomnia Survey. Biol Psychiatry. 2011;69:592– 600.
9 Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011;21(1):41-53.
Contact:
Eisai Inc.
Libby Holman
201-753-1945
libby_holman@eisai.com
SOURCE Eisai Inc.