Eisai Presents New Data on Perampanel and Rufinamide at the 68th Annual American Epilepsy Society Meeting
-- Results of Investigational Studies of Perampanel and Rufinamide Accepted as Late-Breaking Posters --

WOODCLIFF LAKE, N.J., Dec. 5, 2014 /PRNewswire/ -- Eisai Inc. announced today that 16 abstracts highlighting new data on perampanel and rufinamide will be presented at the 68th Annual American Epilepsy Society (AES) meeting, taking place in Seattle, WA from December 5–9, 2014.

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"These data analyses underscore Eisai's commitment to advancing epilepsy care, and we are pleased to present these data to the scientific community," said Lynn Kramer, MD, Chief Clinical Officer, President, Neuroscience & General Medicine PCU Eisai Product Creation Systems, Eisai, Inc.

The following abstracts regarding perampanel and rufinamide are being presented at this year's AES meeting:

Abstract Number

Abstract Name

Perampanel

Late-Breaker

Adjunctive Perampanel (per) for Treatment of Drug-Resistant Primary Generalized

Tonic-Clonic (PGTC) Seizures in Patients (pts) with Idiopathic Generalized Epilepsy (IGE): a Double-Blind, Randomized, Placebo-Controlled Phase III Trial

Late-Breaker

The Effect of Perampanel on Weight Change in Adolescents with Refractory Focal

Epilepsy

Late-Breaker

One-Year Real-World Experience of Perampanel in Elderly Patients with Refractory

Focal Epilepsy

1.325

Assessment of Renal Toxicity in Perampanel-Treated Subjects: Pooled Results From Phase III Clinical Trials      

Poster Session 1

2.276

Review of Suicidality Events in Perampanel Phase III Clinical Studies                 

Poster Session 2

2.279

Assessment of Potential Withdrawal Symptoms of Perampanel in Patients from the Phase III, Double-Blind Clinical Studies and Open-Label Extension Study          
Poster Session 2

2.288

Analysis of Concomitant AEDs and Aggression in Perampanel Phase III Epilepsy Clinical Studies       

Poster Session 2

2.289

Subgroup Analysis by Race in Perampanel Phase III Clinical Studies     

Poster Session 2

2.291

Therapeutic Effect of Perampanel: The Placebo-Adjusted Method             

Poster Session 2

2.293

Effect of Adjunctive Perampanel on Growth and Development in Adolescents With Inadequately Controlled Partial-Onset Seizures          

Poster Session 2

2.294

Effect of Adjunctive Perampanel in Adolescents With Inadequately Controlled Partial-Onset Seizures: Efficacy and Safety Results From Study 235             

Poster Session 2

2.295

Pharmacokinetic and Pharmacodynamic Effects of Adjunctive Perampanel in Adolescents With Inadequately Controlled Partial-Onset Seizures       

Poster Session 2

3.301

Impact of Adding Perampanel to Existing Anti-Epileptic Drug (AED) Therapy on Health-Related Quality of Life (HRQL) as Measured by the Quality of Life in Epilepsy-31-P (QOLIE-31-P) in a Pooled Population of Patients with Partial-Onset Seizures (POS) from 3 Phase III Trials        

Poster Session 3

Rufinamide

Late-Breaker

Effect of Adjunctive Rufinamide in Pediatric Patients With Inadequately Controlled Lennox-Gastaut Syndrome: Interim Pharmacokinetic and Safety Results From Study 303

2.298

Analysis of Real-World Rufinamide Utilization in the Treatment of Epilepsy: Demographic and Socioeconomic Factors

Poster Session 2

2.305

Analysis of Real-World Rufinamide Utilization in the Treatment of Epilepsy: Dosing, Titration, and Concomitant Antiepileptic Drugs
Poster Session 2

FYCOMPA Important Safety Information

WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS

  • 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

Serious Psychiatric and Behavioral Reactions

Hostility- and aggression-related adverse reactions occurred in 12% and 20% of clinical trial patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/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. 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.

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 or 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 randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 10% of placebo-treated patients. Gait disturbance related events were reported in 12% and 16% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 2% of placebo-treated patients. These adverse reactions occurred mostly during the titration phase.

Somnolence and Fatigue
FYCOMPA caused dose-dependent increases in somnolence and fatigue-related events. Somnolence was reported in 16% and 18% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 7% of placebo patients. Fatigue-related events were reported in 12% and 15% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 5% of placebo patients. In the controlled Phase 3 epilepsy clinical trials, these adverse reactions occurred mostly during the titration phase. 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 randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 3% of placebo-treated patients.

Withdrawal of AEDs
A gradual withdrawal is generally recommended with antiepileptic drugs to minimize the potential of increased seizure frequency.

Most Common Adverse Reactions
In clinical trials, the most frequently reported dose-related adverse reactions in patients receiving FYCOMPA 8 mg or 12 mg vs placebo (≥4% and at least 1% higher than the placebo group) included dizziness (36% vs 9%), somnolence (16% vs 7%), fatigue (10% vs 5%), irritability (9% vs 3%), falls (7% vs 3%), nausea (7% vs 5%), ataxia (5% vs 0%), balance disorder (4% vs 1%), gait disturbance (4% vs 1%), vertigo (4% vs 1%), and weight gain (4% vs 1%).

Drug Interactions
FYCOMPA may decrease the efficacy of contraceptives containing levonorgestrel. Plasma levels of FYCOMPA were decreased when administered with carbamazepine, phenytoin and oxcarbazepine. Concomitant use with strong CYP3A inducers such as St. John's wort and rifampin should be avoided. Multiple dosing of FYCOMPA 12 mg/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 Category C and Lactation
FYCOMPA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 a nursing woman.

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 drug substance and has the potential to be abused or lead to drug dependence.

Please see the FYCOMPA (perampanel) CIII Full Prescribing Information

BANZEL Indication and Important Safety Information
BANZEL® (rufinamide) is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in children 4 years and older and adults.

Important Safety Information

Contraindications:
BANZEL is contraindicated in patients with Familial Short QT syndrome.

Warnings:
AEDs increase the risk of suicidal thoughts or behavior in patients. Patients, their caregivers, and families should be informed of the risk and advised to monitor and report any emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior, or thoughts of self-harm. If these symptoms occur, consider if it may be related to the AED or illness because epilepsy itself can increase these risks.

Use of BANZEL has been associated with central nervous system–related adverse reactions, such as somnolence or fatigue, coordination abnormalities, dizziness, gait disturbances, and ataxia.

Precautions:
Formal cardiac ECG studies demonstrated shortening of the QT interval (mean = 20 msec, for doses ≥ 2400 mg twice daily) with BANZEL. Caution should be used when administering BANZEL with other drugs that shorten the QT interval.

Multi-organ hypersensitivity syndrome has been reported in association with BANZEL therapy. In clinical trials, hypersensitivity reactions occurred in children less than 12 years of age and within 4 weeks of starting BANZEL therapy. In addition, rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms and Stevens-Johnson syndrome have been reported in association with rufinamide therapy post marketing. If any of these reactions are suspected, BANZEL should be discontinued and alternative treatment started. All patients who develop a rash while taking BANZEL must be closely supervised.

As with all AEDs, BANZEL should be gradually withdrawn to minimize the risk of increased seizure frequency.

Adverse reactions:
In all patients with epilepsy treated in double-blind, adjunctive therapy studies, the most commonly observed (≥10%) adverse reactions with BANZEL vs placebo, respectively, were headache (25% vs 20%), dizziness (17% vs 10%), fatigue (15% vs 9%), somnolence (13% vs 9%), and nausea (11% vs 7%).

Please see the BANZEL Full Prescribing Information

About FYCOMPA® (perampanel)
FYCOMPA is indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older. FYCOMPA is a non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor antagonist. Glutamate is the primary excitatory neurotransmitter in the central nervous system. The precise mechanism by which FYCOMPA exerts its antiepileptic effects in humans has not been fully elucidated.

Epilepsy is a therapeutic area of focus for Eisai. The company continues to make further contributions to help address the diversified needs of epilepsy patients and their families as part of its corporate human health care (hhc) mission.

About BANZEL® (rufinamide)
BANZEL is an anti-epileptic drug indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults. BANZEL is a triazole derivative that is structurally unrelated to currently marketed antiepileptic drugs (AEDs). The clinical significance of this structural difference has not been established. It is believed to exert its effect by regulating the activity of sodium channels in the brain which carry excessive electrical charges that may cause seizures.

BANZEL is currently available in 200 and 400 mg tablets and in a 40 mg/mL oral suspension formula for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults. It has been on the market since its FDA approval on November 14, 2008.

Eisai Inc.

At Eisai Inc., human health care 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 help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.

Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.

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SOURCE Eisai Inc.

Type Press Release

Date Released December 05, 2014

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