EISAI TO PRESENT LATEST DATA ON LEMBOREXANT AT THE 36TH ANNUAL SLEEP 2022 MEETING

NUTLEY, N.J., June 2, 2022 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today a total of seven poster presentations including the latest data on its in-house discovered orexin receptor antagonist lemborexant (product name: DAYVIGO® CIV) will be given at the 36th annual meeting of the Associated Professional Sleep Societies (SLEEP 2022), to be held from June 4 to June 8, 2022, in Charlotte, NC.

Major poster presentations include the results of a subgroup analysis of the Phase III 304 clinical study on the effect of lemborexant treatment in older adults with insomnia and objectives of short sleep which is characterized by sleeping fewer than six hours (Posters #171 and #172).

"DAYVIGO continues to serve as an important asset to Eisai's neurology portfolio and we look forward to presenting the findings from several analyses at this year's SLEEP Meeting," said Ivan Cheung, Eisai Inc., Senior Vice President, President Neurology Business Group, Eisai Co., Ltd. "Insomnia can lead to daytime consequences; fatigue, difficulty concentrating and irritability, 1, 2 and causes distress or impairs functioning in social and occupational settings.3 Eisai remains committed to our pursuit of helping people suffering from insomnia to help address unmet medical needs."

SLEEP 2022 Presentations

Asset in Product,

Topic, Session, Time (Eastern Time)

Title, Presenter

Lemborexant

Poster presentation

Poster #168

Monday, June 6, 6:15 PM – 7:15 PM

Oral presentation session: O-31

Wednesday, June 8, 3 :15 PM

Subjective Sleep Outcomes with Lemborexant Among

Subjects with Insomnia and Clinically Meaningful Decreases

on the Insomnia Severity Index

Authors: Dr. Thomas Roth, et al

 

Presenter: Dr. Margaret Moline

Lemborexant

Poster presentation

Poster #169

Monday, June 6, 5:15 PM – 6:15 PM

Correlations Between Sleep Parameters and ISI Total Score

in Subjects with Moderate to Severe Insomnia Treated with

Lemborexant

Authors: Dr. Margaret Moline, et al

 

Presenter: Dr. Margaret Moline

Lemborexant

Poster presentation

Poster #170

Monday, June 6, 6:15 PM – 7:15 PM

Effect of Lemborexant on Early Morning Awakening in

Subjects with Severe Problems with Waking Too Early

 

Authors: Dr. Margaret Moline, et al

 

Presenter: Dr. Elizabeth Pappadopulos

Lemborexant

 

Poster presentation

Poster #171

Monday, June 6, 5:15 PM – 6:15 PM

Oral presentation session: O-31

Wednesday, June 8, 4:45 PM

Effect of Lemborexant Treatment on Polysomnographic

Sleep Measures in Older Adults with Insomnia and

Objective Short Sleep

Authors: Dr. Andrew D. Krystal, et al

 

Presenter: Dr. Margaret Moline

 

Lemborexant

Poster presentation

Poster #172

Monday, June 6, 6:15 PM – 7:15 PM

Oral presentation session: O-31

Wednesday, June 8, 5:00 PM

Lemborexant Treatment of Older Adults with Insomnia and

Objective Short Sleep: Rates of Response and Remission

Authors: Dr. Jack D. Edinger, et al

 

Presenter: Dr. Jack D. Edinger

 

Lemborexant

Poster presentation

Poster #173

Monday, June 6, 5:15 PM – 6:15 PM

Lemborexant Exposure is Independent of Race

 

Authors: Dr. Sumit Rawal, et al

 

Presenter: Dr. Margaret Moline

Lemborexant

Poster presentation

Poster #174

Monday, June 6, 6:15 PM – 7:15 PM

Response to Lemborexant in Older Subjects with Insomnia

Disorder and Comorbid Pain at Baseline

 

Authors: Dr. Alan Kaplan, et al

 

Presenter: Dr. Alan Kaplan

 

Please note, the poster presentation time is 5:15 PM7:15 PM on Monday, June 6 with odd numbered poster presentations taking place from 5:15 PM6:15 PM and even numbered poster presentations from 6:15 PM7:15 PM.

Media Inquiries: 
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

Eisai Inc. (U.S.)
TEL: +551-305-0050
Christopher_Vancheri@eisai.com 

Investor Contact: 
Eisai Co., Ltd.
Investor Relations Department
TEL: +81-(0)70-8688-9685

[Notes to editors] 
About Lemborexant (product name: DAYVIGO®
Lemborexant, an orexin receptor antagonist, is Eisai's in-house discovered and developed small molecule that inhibits orexin neurotransmission by binding competitively to the two subtypes of orexin receptors (orexin receptor 1 and 2). Fast on/off receptor kinetics of lemborexant to orexin receptors may influence lemborexant's potential to facilitate improvements in sleep onset and maintenance with minimal morning residual effects. It has been approved for the treatment of insomnia in over 10 countries including Japan, the United States and countries in Asia.

About Eisai Co., Ltd. 
Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai's corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

Leveraging the experience gained from the development and marketing of a treatment for Alzheimer's disease, Eisai aims to establish the "Eisai Dementia Platform." Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a "Dementia Ecosystem," by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com.

About Eisai Inc. 
At Eisai Inc., human health care (hhc) is our mission and is the shared purpose that connects us to those we serve creating a network of powerful relationships that enables us to identify, understand and work to address the needs of people throughout their lives. We boldly push past the boundaries of science and aim to deliver life-changing therapies and health-related solutions that matter to people and society. We bring together science, technology and real-world expertise to pursue a world free from cancer, Alzheimer's disease and other neurodegenerative diseases.

Everything we do is guided by the simple principle that patients and their families come first, and we have a responsibility to listen to and learn from them.

Eisai Inc. is the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd. The company's presence in the U.S. includes three discovery centers as well as commercial, clinical development and global demand organizations. To learn more about Eisai, please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn. For more information on our work in neurology, please visit the Eisai U.S. Neurology LinkedIn page.

INDICATION FOR DAYVIGO 
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

DAYVIGO is contraindicated in patients with narcolepsy.

WARNINGS AND PRECAUTIONS

Central Nervous System (CNS) Depressant Effects and Daytime Impairment:

DAYVIGO can impair daytime wakefulness. CNS depressant effects may persist in some patients up to several days after discontinuing DAYVIGO. Prescribers should advise patients about the potential for next-day somnolence.

Driving ability was impaired in some subjects taking DAYVIGO 10 mg. Risk of daytime impairment is increased if DAYVIGO is taken with less than a full night of sleep remaining or at a higher than recommended dose. If taken in these circumstances, patients should not drive or engage in activities requiring mental alertness.

Use with other classes of CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression, which can cause daytime impairment. Dosage adjustments of DAYVIGO and concomitant CNS depressants may be necessary when administered together. Use of DAYVIGO with other insomnia drugs is not recommended. Patients should be advised not to consume alcohol in combination with DAYVIGO.

Because DAYVIGO can cause drowsiness, patients, particularly the elderly, are at a higher risk of falls.

Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-Like Symptoms: Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions can occur with DAYVIGO. Prescribers should explain these events to patients.

Symptoms similar to mild cataplexy can occur with DAYVIGO and can include periods of leg weakness lasting from seconds to a few minutes, can occur either at night or during the day, and may not be associated with identified triggering event (e.g., laughter or surprise).

Complex Sleep Behaviors: Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake (e.g., preparing and eating food, making phone calls, having sex), have been reported to occur with the use of hypnotics such as DAYVIGO. Events can occur in hypnotic-naïve and hypnotic-experienced persons. Patients usually do not remember these events. Complex sleep behaviors may occur following the first or any subsequent use of DAYVIGO, with or without the concomitant use of alcohol and other CNS depressants. Discontinue DAYVIGO immediately if a patient experiences a complex sleep behavior.

Patients with Compromised Respiratory Function: The effect of DAYVIGO on respiratory function should be considered for patients with compromised respiratory function. DAYVIGO has not been studied in patients with moderate to severe obstructive sleep apnea (OSA) or chronic obstructive pulmonary disease (COPD).

Worsening of Depression/Suicidal Ideation: Incidence of suicidal ideation or suicidal behavior, as assessed by questionnaire, was higher in patients receiving DAYVIGO than placebo (0.3% for DAYVIGO 10 mg, 0.4% for DAYVIGO 5 mg, and 0.2% for placebo).

In primarily depressed patients treated with hypnotics, worsening of depression and suicidal thoughts and actions (including completed suicides) have been reported. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdose is more common in this group of patients; therefore, the lowest number of tablets that is feasible should be prescribed at any one time.

The emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.

Need to Evaluate for Comorbid Diagnoses: Treatment of insomnia should be initiated only after careful evaluation of the patient. Reevaluate for comorbid conditions if insomnia persists or worsens after 7 to 10 days of treatment. Worsening of insomnia or the emergence of new cognitive or behavioral abnormalities may be the result of an unrecognized underlying psychiatric or medical disorder and can emerge during the course of treatment with sleep-promoting drugs such as DAYVIGO.

ADVERSE REACTIONS 
The most common adverse reaction (reported in 5% of patients treated with DAYVIGO and at least twice the rate of placebo) with DAYVIGO was somnolence (10% for DAYVIGO 10 mg, 7% for DAYVIGO 5 mg, 1% for placebo).

DRUG INTERACTIONS 
CYP3A Inhibitors: The maximum recommended dose of DAYVIGO is 5 mg no more than once per night when co-administered with weak CYP3A inhibitors. Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inhibitors.

CYP3A Inducers: Avoid concomitant use of DAYVIGO with moderate or strong CYP3A inducers.

USE IN SPECIFIC POPULATIONS

Pregnancy and Lactation: There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to DAYVIGO during pregnancy.

Healthcare providers are encouraged to register patients in the DAYVIGO pregnancy registry by calling 1-888-274-2378. There are no available data on DAYVIGO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

There are no data on the presence of lemborexant in human milk, the effects on the breastfed infant, or the effects on milk production. Infants exposed to DAYVIGO through breastmilk should be monitored for excess sedation.

Geriatric Use: Exercise caution when using doses higher than 5 mg in patients ≥65 years old.

Renal Impairment: Patients with severe renal impairment may experience an increased risk of somnolence.

Hepatic Impairment: The maximum recommended dose of DAYVIGO is 5 mg in patients with moderate hepatic impairment. DAYVIGO is not recommended in patients with severe hepatic impairment. Patients with mild hepatic impairment may experience an increased risk of somnolence.

DRUG ABUSE AND DEPENDENCE

DAYVIGO is a Schedule IV-controlled substance.

Because individuals with a history of abuse or addiction to alcohol or other drugs may be at increased risk for abuse and addiction to DAYVIGO, follow such patients carefully.

For more information about DAYVIGO, see full Prescribing Information

References:
1. Ferrie JE, et al. Sleep epidemiology – a rapidly growing field. Int J Epidemiol. 2011;40(6):1431–1437. 
2. Roth T. Insomnia: definition, prevalence, etiology and consequences. J Clin Sleep Med. 2007;3(5 Suppl):S7–S10.
3. National Institute of Public Health. Sleep disorders practice guidelines - for the proper usage of sleeping medications and the withdrawal: insomnia medical manual aiming for breaking through (available in Japanese only).

SOURCE Eisai Inc.

Type Press Release

Date Released June 02, 2022

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