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
WOODCLIFF LAKE, N.J., Sept. 19, 2019 /PRNewswire/ -- Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced that new long-term, Phase 3 data and additional analyses of lemborexant will be highlighted in eight presentations at the 2019 World Sleep Congress, taking place September 20-25 in Vancouver, Canada. An additional poster will feature new survey findings about the perceptions of insomnia and sleeping difficulties amongst patients and household cohabitants, including next-day functioning. Lemborexant is an investigational agent being studied for the treatment of insomnia, a sleep-wake disorder, and as a potential treatment of irregular sleep-wake rhythm disorder (ISWRD) in patients with Alzheimer's disease.
Presentations include new long-term (12-month) effectiveness and safety results, including an assessment of lemborexant compared to placebo on subject-reported fatigue, from SUNRISE 2 (Study 303); an analysis of the effect of lemborexant on sleep architecture in older adults with insomnia disorder from SUNRISE 1 (Study 304), the first Phase 3 head-to-head study including pre-specified endpoints versus zolpidem ER; and a pooled analysis of subject-reported outcomes from both Phase 3 studies which assessed the effect of lemborexant on sleep onset and maintenance and insomnia disease severity:
-- Oral 1: Long-term Effectiveness and Safety of Lemborexant in Adults with
Insomnia Disorder: 12-month Results From SUNRISE 2
-- Oral 1: Effect of Lemborexant Compared With Placebo and Zolpidem
Extended Release on Sleep Architecture in Older Adults with Insomnia
Disorder
-- Poster 153: Long-Term Effect of Lemborexant on Fatigue in Subjects with
Insomnia Disorder: Patient-Reported Outcome from the 6-Month
Placebo-Controlled Treatment Period of the Phase 3 Study SUNRISE 2
-- Poster 118: Impact of Lemborexant Treatment on the Patient Global
Impression - Insomnia Scale
-- Poster 160: Patient-reported Sleep Onset and Sleep Maintenance: Pooled
Responder Analyses of Lemborexant Phase 3 Studies
-- Poster 131: The Impact of Lemborexant Treatment on Insomnia Disease
Severity: Results From a Pooled Analysis of Two Phase 3 Studies
-- Poster 127: Do Insomnia Patients in Insomnia Clinical Trials Endorse
Daytime Sleepiness?
Eisai will also present a poster on the findings from "How America Sleeps and Wakes," a company-sponsored survey, conducted by The Harris Poll, which evaluated the perceptions of both patients and household cohabitants regarding the burden of insomnia and sleep difficulties on next-day functioning.
-- Poster 139: Insomnia Impacts the Patient and the Household: Perceptions
of the Burden of Insomnia on Next-Day Functioning
"We look forward to sharing new information that expand the understanding of the long-term effectiveness and safety data of lemborexant, as well as its effect on multiple measures of insomnia in a broad age range of patients," said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "Given Eisai's focus on patients and their families, we are especially pleased to share results from our patient and household cohabitant survey, "How America Sleeps and Wakes," as we seek to further understand the unmet needs of people living with insomnia and its impact on an entire household."
Additionally, results of a pre-clinical study of lemborexant in the first mouse model of ISWRD in Alzheimer's disease will be featured in an oral presentation:
-- Oral 30: Senescence-Accelerated Mouse Prone-8 SAMP8 Mice As A
Preclinical Model For Irregular Sleep Wake Rhythm Disorder and Efficacy
Of The Dual Orexin (Hypocretin) Receptor Antagonist Lemborexant
Information about completed and ongoing lemborexant clinical studies is available at clinicaltrials.gov.
Earlier this year, the U.S. 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 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.
<Notes to editors>
1. About LemborexantLemborexant is a novel investigational 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, suggesting that inhibiting inappropriate orexin signaling may
enable initiation and maintenance of sleep. Eisai is investigating
lemborexant as a potential treatment option for multiple sleep-wake
disorders, such as insomnia. 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.
2. About SUNRISE 1 (Study 304)(1 )SUNRISE 1 was a multicenter, randomized,
double-blind, placebo-controlled, active comparator, parallel-group study
evaluating the efficacy and safety of lemborexant in 1,006 male or female
adult patients 55 years and older (45 percent of patients were 65 years
and older) with insomnia disorder conducted in North America and Europe.
SUNRISE 1 included a pre-randomization phase of up to 35 days (including
a two-week placebo run-in period) and a randomization phase comprised of
a 30-day treatment period and a minimum two-week period without treatment
prior to the end-of-study visit. 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).
The primary objective for SUNRISE 1 was to demonstrate using
polysomnography that lemborexant at either the 5 mg or 10 mg dose is
superior to placebo on objective sleep onset, as measured by latency to
persistent sleep after the last two nights of one month of treatment. Key
secondary objectives included change from baseline in sleep efficiency
and wake after sleep onset for both lemborexant doses compared to
placebo, and wake after sleep onset in the second half of the night for
both lemborexant doses compared to zolpidem ER, each after the last two
nights of one month of treatment.
3. About SUNRISE 2 (Study 303)(2)SUNRISE 2 was a 12-month multicenter,
global, randomized, controlled, double-blind, parallel-group study of the
efficacy and safety of lemborexant in 949 male or female adult
participants 18 to 88 years of age with insomnia disorder. SUNRISE 2
included a pre-randomization phase of up to 35 days (including a two-week
placebo run-in period) and a randomization phase comprised of a six-month
placebo-controlled treatment period, a six-month period of only active
treatment and a two-week period without treatment prior to the
end-of-study-visit. In this study, during the placebo-controlled
treatment period, patients were randomized to receive placebo or one of
two treatment regimens (lemborexant 5 mg or 10 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. The primary
objective was to determine the efficacy of lemborexant 5 mg and 10 mg
compared to placebo on patient-reported (subjective) sleep onset latency
after six months of treatment. Key secondary endpoints were mean change
from baseline in subjective sleep efficiency and subjective wake after
sleep onset (sWASO) for lemborexant 5 mg and 10 mg compared to placebo
after six months of treatment.
4. About Sleep DisordersPopulation studies show that sleep disorders affect
many more people worldwide than previously thought.(3) Insomnia symptoms
affect approximately 30 percent 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, including an
increased risk of hypertension, accidental injury, diabetes, obesity,
depression, heart attack, stroke and dementia, as well as adverse effects
on mood and behavior.(5,7)
()Experimental studies in animals and humans provide evidence of
associations between sleep and disease risk factors, diseases and
mortality.(8) Studies suggest an optimal sleep duration between seven and
eight hours.(9) Women are
1.4 times more likely than men to suffer from insomnia.(10) 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.(11)
5. 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. A multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of the efficacy and safety of lemborexant in subjects 55 years and older with insomnia disorder. (E2006-G000-304). (Clinicaltrials.gov Identifier NCT02783729). 2018. Unpublished data on file.
(2 )Eisai Inc. A long-term multicenter, randomized, double-blind, controlled, parallel-group study of the safety and efficacy of lemborexant in subjects with insomnia disorder (E2006-G000-303). (Clinicaltrials.gov Identifier NCT02952820). 2018. Unpublished data on file.
(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) Pase MP, Himali JJ, Grima NA, et al. Sleep architecture and the risk of incident dementia in the community. Neurology. 2017;89(12):1244-1250.
(8) Cappuccio FP, et al. Sleep and cardio-metabolic disease. Curr Cardiol Rep. 2017;19:110.
(9) 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.
(10 )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.
(11 )Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011;21(1):41-53.
Contact:
Eisai Inc.
James Merse
551-502-2710
James_Merse@eisai.com
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