WOODCLIFF LAKE, N.J., April 24, 2019 /PRNewswire/ -- Eisai Inc. today announced that one oral presentation and 20 poster presentations from its neurology portfolio will be featured at the American Academy of Neurology's (AAN) Annual Meeting, May 4-10, in Philadelphia. The data presented will include studies in epilepsy and sleep-wake disorders.

An oral presentation of results from three clinical studies assessing next-morning residual effects of lemborexant is scheduled at 2:06 p.m. on Thursday, May 9, during the Sleep Science and Therapy Updates session (S46). Discovered and developed by Eisai's R&D team, lemborexant is currently being evaluated by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia, a sleep-wake disorder, with a Prescription Drug User Fee Act (PDUFA) target date set for December 27, 2019.

Eisai will present seizure freedom rates as part of three posters on Study 311 – which is a study that supported the FDA approval of FYCOMPA in pediatric patients four years and older for the treatment of partial-onset seizures (POS). In addition, Eisai will present a key study examining the effects of short half-life vs long half-life antiepileptic drugs (AEDs) on the rate of inpatient hospitalizations in patients with uncontrolled epilepsy as well as data on real-world clinical care with FYCOMPA.

FYCOMPA data presentations will also include real-world analyses evaluating the use of the AED in all-cause and epilepsy-related hospitalizations in adult and adolescent patients with epilepsy; most notably, one analysis that compares FYCOMPA to lacosamide.

"The breadth of data we are presenting at AAN highlights how Eisai is breaking through with significant research to find medications for people living with highly complex, neurologic disorders," said Ivan Cheung, Chairman and CEO, Eisai Inc. "As we continue our relentless pursuit of innovation, we look forward to sharing our latest data in sleep-wake disorders and epilepsy with the scientific community at AAN and upcoming medical congresses around the world."

In addition to data presentations, AAN marks the first neurology congress at which Eisai and its partner Empatica will co-promote the Embrace2 device. Embrace2 is the first FDA-cleared, wrist-worn wearable within the field of epilepsy for detecting patterns that may be associated with convulsive seizures during periods of rest in patients ages six to adult.

Details for the presentations are as follows:

Portions of this release discuss investigational uses for FYCOMPA and an investigational agent, lemborexant. It is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses or agents will successfully complete clinical development or gain FDA approval.

INDICATION FOR FYCOMPA
FYCOMPA^® (perampanel) is indicated in patients with epilepsy aged 4 years and older for partial-onset seizures (POS) with or without secondarily generalized seizures and adjunctive therapy for patients aged 12 years and older for primary generalized tonic-clonic (PGTC) seizures.

IMPORTANT SAFETY INFORMATION FOR FYCOMPA

SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
In the partial-onset seizures clinical trials, hostility- and aggression-related adverse reactions occurred in 12% and 20% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 6% of patients in the placebo group. These effects were dose-related and generally appeared within the first 6 weeks of treatment, although new events continued to be observed through more than 37 weeks. These effects in FYCOMPA-treated patients led to dose reduction, interruption, and discontinuation more frequently than placebo-treated patients. Homicidal ideation and/or threat have also been reported postmarketing in patients treated with FYCOMPA. The combination of alcohol and FYCOMPA significantly worsened mood and increased anger. Patients taking FYCOMPA should avoid the use of alcohol. Patients, their caregivers, and families should be informed that FYCOMPA may increase the risk of psychiatric events. Patients should be monitored during treatment and for at least one month after the last dose of FYCOMPA, and especially when taking higher doses and during the initial few weeks of drug therapy (titration period) or at other times of dose increases. Similar serious psychiatric and behavioral events were observed in the primary generalized tonic-clonic (PGTC) seizure clinical trial.

SUICIDAL BEHAVIOR AND IDEATION
Antiepileptic drugs (AEDs), including FYCOMPA, increase the risk of suicidal thoughts or behavior in patients. Anyone considering prescribing FYCOMPA or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Patients, their caregivers, and families should be informed of the risk and advised to monitor and immediately report the emergence or worsening of depression, suicidal thoughts or behavior, thoughts about self-harm and/or any unusual changes in mood or behavior. Should suicidal thoughts and behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

DIZZINESS AND GAIT DISTURBANCE
FYCOMPA caused dose-related increases in events related to dizziness and disturbance in gait or coordination. Dizziness and vertigo were reported in 35% and 47% of patients in the partial-onset seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 10% of placebo-treated patients. Gait disturbance related events were reported in 12% and 16% of patients in the partial-onset seizure clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 2% of placebo-treated patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the PGTC seizure clinical trial.

SOMNOLENCE AND FATIGUE
FYCOMPA caused dose-dependent increases in somnolence and fatigue-related events. Somnolence was reported in 16% and 18% of patients in the partial-onset seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 7% of placebo-treated patients. Fatigue-related events were reported in 12% and 15% of patients in the partial-onset seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 5% of placebo-treated patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the PGTC seizure clinical trial. Patients should be advised against engaging in hazardous activities requiring mental alertness, such as operating motor vehicles or dangerous machinery, until the effect of FYCOMPA is known.

FALLS
Falls were reported in 5% and 10% of patients in the partial-onset seizure clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 3% of placebo-treated patients.

DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS)
DRESS, also known as multiorgan hypersensitivity, has been reported in patients taking AEDs, including FYCOMPA. DRESS may be fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement. If signs or symptoms are present, immediately evaluate the patient and discontinue FYCOMPA if an alternative etiology for signs or symptoms cannot be established.

WITHDRAWAL OF AEDs
A gradual withdrawal is generally recommended with AEDs to minimize the potential of increased seizure frequency, but if withdrawal is a response to adverse events, prompt withdrawal can be considered.

MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in patients aged 12 years and older receiving FYCOMPA (≥5% and ≥1% higher than placebo) include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety. Adverse reactions in patients aged 4 to <12 years were generally similar to patients aged 12 years and older.

DRUG INTERACTIONS
FYCOMPA may decrease the efficacy of contraceptives containing levonorgestrel. Plasma levels of perampanel were decreased when administered with known moderate and strong CYP3A4 inducers, including, carbamazepine, phenytoin, or oxcarbazepine. Multiple dosing of FYCOMPA 12 mg per day enhanced the effects of alcohol on vigilance and alertness, and increased levels of anger, confusion, and depression. These effects may also be seen when FYCOMPA is used in combination with other CNS depressants.

PREGNANCY AND LACTATION
Physicians are advised to recommend that pregnant patients taking FYCOMPA enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Caution should be exercised when FYCOMPA is administered to pregnant or nursing women as there are no adequate data on the developmental risk associated with use in pregnant women, and no data on the presence of perampanel in human milk, the effects on the breastfed child, or the effects of the drug on milk production.

HEPATIC AND RENAL IMPAIRMENT
Use in patients with severe hepatic or severe renal impairment is not recommended. Dosage adjustments are recommended in patients with mild or moderate hepatic impairment. Use with caution in patients with moderate renal impairment.

DRUG ABUSE AND DEPENDENCE
FYCOMPA is a Schedule III controlled substance and has the potential to be abused and lead to drug dependence and withdrawal symptoms including anxiety, nervousness, irritability, fatigue, asthenia, mood swings, and insomnia.

Please see full Prescribing Information, including Boxed WARNING.  

Indications For Use For Embrace2
Embrace2 is a prescription only, single-patient, device that is indicated for use as an adjunct to seizure monitoring of adults and children ages 6 and up in home or healthcare facilities during periods of rest. The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with generalized tonic-clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert to a designated caregiver. The system records and stores data from Accelerometer, EDA, and Temperature sensors for subsequent review by a trained healthcare professional.

Limitations

• The device does not predict seizure onset.
• The device is not intended to be used during physical activity.
• The safety and effectiveness of the Embrace System has not been established in monitoring signals that may be associated with seizures other than generalized tonic-clonic convulsive seizures.
• The device is not intended to be used to guide medical therapy decisions.
• The device is not intended to be used as a stand-alone monitoring device.

Important Information For Embrace2
There is no guarantee that Embrace2 and the Alert App will detect every single seizure and deliver alerts accordingly. The system is not meant to substitute or alter your current seizure monitoring/management practices. The main risk is the device or app failing to detect a convulsive seizure, or failing to deliver an alert due to connection issues. Timely delivery of notifications to caregivers requires certain conditions to be met. If the user or caregiver changes their seizure management practices and relies too heavily on Embrace2, this may lead to less than adequate supervision. Patients should discuss the risks and benefits with their physician. Please see the Instructions for Use for additional information available at www.bit.ly/2UT279M.

About FYCOMPA 
FYCOMPA is a prescription medicine used in people with epilepsy aged 4 and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures, and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older.

FYCOMPA, a unique oral medication, is a selective, non-competitive AMPA (alpha-amino-3-hydroxy-5- methyl-4-isoxazolepropionic acid) receptor antagonist. The precise mechanism by which FYCOMPA exerts its antiepileptic effects in humans is unknown. In a pharmacokinetic study, it has been demonstrated that because of its long half-life, a missed dose of FYCOMPA does not significantly impact plasma levels.

FYCOMPA is supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets, and as a 0.5 mg/mL oral suspension formulation. FYCOMPA has been designated by the U.S. Drug Enforcement Administration as a federally-controlled substance (CIII).

About Embrace2
Embrace2 is an epilepsy smartband that detects patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures, and immediately alerts caregivers. The device received FDA clearance for seizure monitoring in adults in January of 2018. In December of 2018,  Embrace2 received FDA clearance for seizure monitoring in children as young as six years old, making the device the first non-EEG based physiology signal seizure monitoring system to be cleared by the FDA for use in a pediatric population, highlighting the challenges and complicated processes that come with this type of testing for children. Embrace2 was CE certified in Europe as a medical device for seizure detection in April 2017. Embrace2 has been listed as one of the 18 things that made the world a better place in 2018 by WIRED.

About Epilepsy
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. Epilepsy is one of the most common neurological disorders, which affects about 3.4 million people in the United States, including 470,000 children. Children with uncontrolled seizures are at greater risk for sudden unexpected death in epilepsy (SUDEP), which is relatively uncommon in childhood, but the risk increases if epilepsy persists into adulthood.

Partial-onset seizures are the most common type of seizure seen in people with epilepsy, accounting for 60 percent of all seizures. Convulsive seizures account for up to 25 percent of all epilepsy, with primary generalized tonic-clonic seizures being one of the most common and severe forms of seizures.

Missed medication doses are the number one cause of breakthrough seizures, which can cause significant injury to patients. People who experience breakthrough seizures have an increased risk of fractures or head injuries, emergency room (ER) visits, and hospitalization, as well as an associated increase in healthcare costs. 

About Lemborexant
Lemborexant 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.

About Sleep-Wake Disorders
Population studies show that sleep-wake disorders affect many more people worldwide than previously thought. Insomnia symptoms affect approximately 30 percent of the adult population worldwide. 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.

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.

Experimental studies in animals and humans provide evidence of associations between sleep and disease risk factors, diseases, and mortality. Studies suggest an optimal sleep duration between seven and eight hours.

Women are 1.4 times more likely than men to suffer from insomnia. 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.

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). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. 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

Contact:

Media Inquiries
James Merse
Eisai Inc.
201-746-2088
media@eisai.com

SOURCE Eisai Inc.