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Eisai Inc. (ESALF.PK) Presents New Data Analyses on FYCOMPA™ (perampanel) at American Epilepsy Society Annual Meeting


12/5/2013 6:28:35 AM

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WOODCLIFF LAKE, N.J., Dec. 5, 2013 /PRNewswire/ -- Today, Eisai Inc. announced that 16 abstracts highlighting new data analyses on FYCOMPA (perampanel) will be presented at the 67th annual American Epilepsy Society (AES) meeting, taking place in Washington, D.C. from December 6 10.

(Logo: http://photos.prnewswire.com/prnh/20120413/MM87168LOGO)

"These data analyses highlight Eisai's clinical research with FYCOMPA, reinforcing our commitment to the epilepsy community," said Lynn Kramer, MD, President of the Neuroscience and General Medicine Product Creation Unit and Chief Clinical Officer of Eisai Product Creation Systems, Eisai's research and development organization.

The following abstracts regarding perampanel are being presented at this year's AES Meeting:

Abstract Number

Abstract Name

1.140

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

Poster Session 1

1.141

Lack of Effect of Perampanel on QT Interval Duration: Results From a Thorough QT Analysis and Pooled Phase III Clinical Trials

Poster Session 1

1.142

Efficacy and Safety of Perampanel in the Subgroup of Elderly Patients Included in the Phase III Epilepsy Clinical Trials

Poster Session 1

1.143

Pharmacokinetics of Perampanel: Results From Phase I Clinical Pharmacology Studies

Poster Session 1

1.144

GABA vs. Non-GABA Mechanism of Action of Concomitant Antiepileptic Drugs: Post-hoc Analysis of Pooled Perampanel Phase III Studies

Poster Session 1

1.145

Subgroup Analysis by Gender in Perampanel Phase III Studies of Patients Diagnosed With Partial-Onset Seizures

Poster Session 1

1.146

Review of Psychiatric and Behavioral Events in Perampanel Clinical Studies

Poster Session 1

1.147

Pooled Perampanel Phase III Trials: Time to Onset and Duration for Most Common Adverse Events

Poster Session 1

1.154

Evaluation of Abuse Potential of Perampanel

Poster Session 1

1.230

Efficacy and Safety of Adjunct Perampanel Based on Number of Antiepileptic Drugs at Baseline and Baseline Predictors of Efficacy: Phase III Post-Hoc Analysis

Poster Session 1

2.048

Lesional vs. Non-lesional Partial Epilepsy: Post-hoc Analysis of Pooled Perampanel Phase III Studies

Poster Session 2

2.049

Efficacy and Safety of Perampanel in Patients With Neurologic & Psychiatric Comorbidities: Post-hoc Analysis of Phase III Epilepsy Trials

Poster Session 2

2.050

Analysis of Aggression in Perampanel Phase III Epilepsy Clinical Trials

Poster Session 2

2.063

Effect of Ketoconazole on Perampanel Pharmacokinetics

Poster Session 2

2.148

Exploration of Adverse Events by Region, and Detailed Focus on Psychiatric Events, With Long-term Open-label Perampanel Treatment

Poster Session 2

3.211

Long-term Retention, and Reasons for Discontinuations, With Perampanel Treatment in Pharmacoresistant Focal Seizures

Poster Session 3

FYCOMPA (perampanel) was approved by the U.S. Food and Drug Administration (FDA) in October 2012 as an adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 and older. It is currently awaiting final scheduling designation by the U.S. Drug Enforcement Administration (DEA), at which time FYCOMPA will become available in U.S. pharmacies to patients with a valid prescription.

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 hepaticor 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.

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, affecting 2.2 million people in the United States. About 60 percent of people with epilepsy have partial-onset seizures. In about 25 to 30 percent of patients with epilepsy, seizures cannot be controlled with treatment.

About FYCOMPA (perampanel)

FYCOMPA is an oral medication and is the first FDA-approved 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.

Discovered and developed by Eisai, FYCOMPA has been approved in more than 30 countries.

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.

Media Inquiries

Investor Inquiries

Laurie Landau

Alex Scott

Eisai Inc.

Eisai Inc.

201-746-2510

201-746-2177

Laurie_Landau@eisai.com

Alex_Scott@eisai.com

SOURCE Eisai Inc.



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