Pivotal Phase 3 Study of DAYVIGO(TM) (lemborexant) for the T
WOODCLIFF LAKE, N.J., Dec. 27, 2019 /PRNewswire/ -- Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced that JAMA Network Open (www.jamanetwork.com) published results of SUNRISE 1 (Study 304), a pivotal Phase 3 head-to-head study that compared DAYVIGO™ (lemborexant) to placebo and an active comparator in patients with insomnia disorder.1 In this study, DAYVIGO therapy significantly improved both sleep onset and sleep maintenance compared with placebo.
"We are pleased to share these important study results in JAMA Network Open," said Lynn Kramer, MD, Chief Clinical Officer, Neurology Business Group, Eisai. "The study featured in this publication provides insights into why this agent may make an important difference for patients living with insomnia."
SUNRISE 1 was a global, randomized, double-blind, placebo-controlled, active comparator parallel-group study of 1,006 adults 55 years of age or older with insomnia disorder receiving DAYVIGO 5 mg or 10 mg, an active comparator or placebo for one month at bedtime. The primary study endpoint was the change from baseline in latency to persistent sleep for DAYVIGO therapy versus placebo. Key secondary endpoints were changes from baseline in sleep efficiency and wake after sleep onset compared with placebo, and wake after sleep onset in the second half of the night compared with the active comparator. Treatment-emergent adverse events reported in ≥2% of participants in any active treatment group included headache (6.2% for placebo, 5.3% for active comparator, 6.4% for DAYVIGO 5 mg, and 4.9% for DAYVIGO 10 mg) and somnolence (1.9% for placebo, 1.5% for active comparator, 4.1% for DAYVIGO 5 mg, and 7.1% for DAYVIGO 10 mg). Full study results can be accessed in the JAMA Network Open publication.
DAYVIGO was approved by the U.S. Food and Drug Administration on December 20, 2019 for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.2 The FDA has recommended that DAYVIGO be classified as a controlled substance and this recommendation has been submitted to the U.S. Drug Enforcement Administration (DEA). DAYVIGO will be commercially available following scheduling by the DEA, which is expected to occur within 90 days of the product's approval. The Full Prescribing Information is available here.
JAMA Network Open is an international, peer-reviewed, open access, general medical journal, and is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications.
<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. In individuals with sleep-wake disorders, it is possible that orexin signaling that regulates wakefulness is not functioning normally.
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
WARNINGS AND PRECAUTIONS
USE IN SPECIFIC POPULATIONS
DRUG ABUSE AND DEPENDENCE
For more information about DAYVIGO, see full Prescribing Information.
2. About Sleep Disorders
Population studies show that sleep disorders affect many more people worldwide than previously thought.3 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, which can lead to daytime consequences, such as fatigue, difficulty concentrating, and irritability.5,6
Sleeping well is essential for good health, including brain health. Poor sleep is associated with a wide range of health consequences.5
Experimental studies in animals and humans provide evidence of associations between sleep and disease risk factors, diseases, and mortality.7 Studies suggest an optimal sleep duration between seven and eight hours.8
Women are 1.4 times more likely than men to suffer from insomnia.9 Older adults also have 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.10
3. 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.
1 Rosenberg R, et al. Comparison of lemborexant with placebo and zolpidem extended release in older adults with insomnia disorder: A phase 3 randomized clinical trial. JAMA Netw Open. 2019
2 Eisai Inc. DAYVIGO Full Prescribing Information. 2019.
3 Ferrie JE, et al. Sleep epidemiology – a rapidly growing field. Int J Epidemiol. 2011;40(6):1431–1437.
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 Ohayon MM, et al. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6(2):97-111.
7 Cappuccio FP, et al. Sleep and cardio-metabolic disease. Curr Cardiol Rep. 2017;19:110.
8 Cappuccio FP, et al. Sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. Sleep. 2010;33(5):585-592.
9 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.
10 Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011;21(1):41-53.
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