Eisai presentations at the Annual Meeting of the American Epilepsy Society (AES) included key data on long-term convulsive seizure-freedom rates of adjunctive perampanel (marketed as FYCOMPA® CIII) in adolescent patients, monotherapy in partial-onset
seizures and healthcare utilization associated with perampanel therapy
- About 31% of patients with secondarily generalized (SG) and 50% of those with primarily generalized tonic-clonic (PGTC) seizures experienced convulsive seizure-freedom at year three in open-label extension study in adolescents
- Analysis of extrapolation to monotherapy use demonstrated perampanel was effective and well-tolerated regardless of the antiepileptic drugs (AEDs) used in combination for patients with partial seizures
- For patients on 1-2 AEDs, perampanel was associated with significant reductions in all-cause hospitalizations, epilepsy-related hospitalizations and outpatient visits

WOODCLIFF LAKE, N.J., Dec. 6, 2017 /PRNewswire/ -- Eisai Inc. presented eight posters on perampanel (marketed as FYCOMPA® CIII) at the American Epilepsy Society (AES) Annual Meeting in Washington, D.C. The poster presentations included analyses of convulsive seizure-freedom rates, long-term retention rates and the extrapolation of perampanel to monotherapy use for partial-onset seizures.  Additionally, open-label extension studies now provide additional data for perampanel out to four years, and new analyses in patients treated with perampanel saw decreased health care utilization. Approximately 22 other posters about research on perampanel's safety profile and effectiveness were also presented at the meeting.

Eisai logo. (PRNewsFoto/Eisai Inc.)

Perampanel was approved as monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy 12 years of age or older on July 26th. In addition to the new monotherapy use in POS, FYCOMPA is also approved for adjunctive use in POS and primary generalized tonic-clonic seizures (PGTC) in patients with epilepsy 12 years of age and older.

"Convulsive seizure-freedom should be the goal of every physician treating epilepsy patients," said Jesus Eric Piña-Garza, M.D., Pediatric Neurologist, Tri-Star Medical Group Children's Specialists. "The post-hoc sub-group analysis presented at AES is reflective of real-world data and showed that about 31 percent of patients with secondarily-generalized (SG) seizures and 50 percent of those with primarily generalized tonic-clonic seizures experienced convulsive seizure-freedom at year three with adjunctive perampanel therapy. These results, even with the limitations of a long-term open-label study, are very encouraging for anybody involved in the treatment of those affected by convulsions."

"Experiencing freedom from seizures, especially convulsive seizures, is a key objective in the treatment of epilepsy, and there is growing interest among doctors in the safety and efficacy of monotherapy AED treatment options like perampanel," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "The long-term data and monotherapy extrapolation analyses are part of Eisai's commitment to continually advancing our understanding of epilepsy and its treatment. The significant seizure-freedom noted in our adjunctive trials for patients with SG seizures is very important, given the risks for these patients."

FYCOMPA is approved in 55 countries and has been prescribed to more than 100,000 patients worldwide.

This release discusses investigational uses for an FDA-approved product. It is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain FDA approval.


Some of the key posters presented included data on seizure-freedom rates in the open-label extension studies and extrapolation of monotherapy from Phase 3 trials:

Assessment of the Long-Term Efficacy and Safety of Adjunctive Perampanel in Adolescent Patients: Post-Hoc Analysis of Open-Label Extension (OLEx) Studies
Adjunctive perampanel (up to 12 mg/day) previously demonstrated efficacy and tolerability in Phase 2 and Phase 3 studies in adult and adolescent patients. Patients who completed these studies were eligible to enter open-label extension studies. Patients with both secondary generalized (SG) seizures and primary generalized tonic-clonic (PGTC) seizures were evaluated annually to assess median percent change in SG and PGTC seizure frequency per 28 days. In the studies, seizure-freedom rates for SG and PGTC seizures were defined as the proportion of patients who completed the study and were free from SG or PGTC seizures during the corresponding year of the treatment assessment.

Proportion of patients who achieved seizure-freedom in the open-label extension studies:


Patients with SG Seizure-Freedom

Patients with PGTC Seizure-Freedom

Year 1

22.9% (n=25/109)

21.1% (n=4/19)

Year 2

24.5% (n=13/53)

35.3% (n=6/17)

Year 3

30.6% (n=11/36)

50.0% (n=3/6)

Year 4

39.1% (n=9/23)

100.0% (n=1/1)

At year 3, 31% of patients with SG and 50% of patients with PGTC experienced convulsive seizure-freedom. In the studies, the overall incidence of treatment-emergent adverse events (TEAEs) was highest during the first year of perampanel exposure (SG seizures, n=72 [65.5%]; PGTC seizures, n=15 [78.9%]). The most common TEAEs were dizziness, somnolence and nasopharyngitis for both patients with SG seizures and PGTC seizures.

Extrapolation of Efficacy and Safety Data of Adjunctive Perampanel (PER) from Phase 3 Trials in Patients with Partial Seizures to Evaluate PER as Monotherapy
In three Phase 3 trials of adjunctive perampanel for patients with partial seizures, perampanel was effective and well-tolerated regardless of the AEDs used in combination, suggesting that the efficacy and safety of perampanel are not dependent on the presence of any single or combination of concomitant AEDs. In all perampanel-treated subgroups, the most common TEAE was dizziness, and there were no notable differences in the types of TEAEs across subgroups, including somnolence and headache. This analysis was part of the data submitted to the FDA, supporting the recent approval of perampanel for monotherapy use for partial-onset seizures in the US.

Impact of Adjunctive Perampanel on Healthcare Resource Utilization Based on the Number of Baseline Antiepileptic Drugs
A large healthcare insurance claims database covering 260 million lives was used to identify perampanel patients diagnosed with epilepsy or non-febrile convulsions. Patients (n=2,423) were stratified by the number of AEDs used during the 180 day pre-perampanel period. For patients on 1-2 AEDs, perampanel was associated with significant reductions in all-cause hospitalizations, epilepsy related hospitalizations and outpatient visits.

Clinical Factors Associated with a Major Response (≥ 75% Reduction in Seizure Frequency per 28 Days) in Phase 3 Trials of Adjunctive Perampanel in Patients with Partial Seizures: Post-hoc Multivariate Analysis
A post-hoc multivariate analysis was conducted to identify predictive factors for achieving a major response (≥ 75% reduction in seizure frequency per 28 days from baseline) in the three POS Phase 3 trials. The multivariate analysis found that one of the best predictors of a major response was the presence of SG convulsive seizures at baseline. The other two best predictors of response included increased age at diagnosis and increased perampanel plasma concentrations.  

Retrospective, Phase 4 Study of Perampanel in Real-World Clinical Care of Patients with Epilepsy: An Interim Analysis
This ongoing, multicenter, non-interventional study of patients diagnosed with epilepsy and who initiated perampanel therapy was designed to assess retention rate, safety and dosing experience with perampanel administered during routine clinical care.  The interim analysis included 187 patients and found that close to 60% of epilepsy patients receiving perampanel who were followed for 24 months (n=48/85; 58.5%) remained on treatment. The mean maximum perampanel dose was 7.1 mg and the most common reported TEAEs were dizziness, (9.1%), somnolence (5.3%) and aggression (4.3%).

About Epilepsy
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. According to the Institute of Medicine, epilepsy is one of the most common neurological disorders, which affects about 3.4 million people in the United States. Partial-onset seizures are the most common type of seizure seen in people with epilepsy, accounting for 60 percent of all seizures.

Generalized seizures account for approximately 40 percent of all epilepsy, with primary generalized tonic-clonic seizures being one of the most common and severe forms of generalized seizures. Convulsive seizures can cause significant injury to patients from falling down suddenly and are the most important risk factor associated with sudden unexpected death in epilepsy (SUDEP), making them one of the most severe forms of epileptic seizures.

FYCOMPA® (perampanel) is indicated in patients with epilepsy 12 years of age and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures and adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures.





Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking FYCOMPA

These reactions occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression

Advise patients and caregivers to contact a healthcare provider immediately if any of these reactions or changes in mood, behavior, or personality that are not typical for the patient are observed while taking FYCOMPA or after discontinuing FYCOMPA

Closely monitor patients particularly during the titration period and at higher doses

FYCOMPA should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening

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.

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.

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.

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 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.

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. 

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.

The most common adverse reactions in patients 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.

FYCOMPA may decrease the efficacy of contraceptives containing levonorgestrel. Plasma levels of FYCOMPA were decreased when administered with 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.

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.

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.

FYCOMPA is a Schedule III controlled substance and has the potential to be abused and lead to drug dependence.

Please see accompanying Full Prescribing Information for FYCOMPA (perampanel), including Boxed WARNING.

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.




Media Inquiries 

Investor Inquiries

Laurie Landau

Ivor Macleod

Eisai Inc. 

Eisai Inc.






SOURCE Eisai Inc.

Type Press Release

Date Released December 06, 2017

Mar 23, 2023

Study Findings in Patients with Recurrent or Advanced Endometrial Carcinoma Who Were Rechallenged With Platinum Chemotherapy Will Be Featured in an Oral Plenary Session Additional Subgroup...

Mar 22, 2023

Presentations Explore ARIA with the Use of Antiplatelets or Anticoagulants and Isolated ARIA-H in Patients from Eisai's Lecanemab Phase 3 Confirmatory Clarity AD Study in Early Alzheimer's Disease...

Mar 19, 2023

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") today announced the publication of updated results from an evaluation estimating the societal value of anti-amyloid-beta (Aβ)...

Alerts - Release page
* Required Fields