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

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

PR Newswire

WOODCLIFF LAKE, N.J., Dec. 5, 2013

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

                Poster Session 1
                Lack of Effect of Perampanel on QT Interval Duration: Results
                From a Thorough QT Analysis and Pooled Phase III Clinical
1.141           Trials

                Poster Session 1
                Efficacy and Safety of Perampanel in the Subgroup of Elderly
1.142           Patients Included in the Phase III Epilepsy Clinical Trials

                Poster Session 1
                Pharmacokinetics of Perampanel: Results From Phase I Clinical
1.143           Pharmacology Studies

                Poster Session 1
                GABA vs. Non-GABA Mechanism of Action of Concomitant
                Antiepileptic Drugs: Post-hoc Analysis of Pooled Perampanel
1.144           Phase III Studies

                Poster Session 1
                Subgroup Analysis by Gender in Perampanel Phase III Studies of
1.145           Patients Diagnosed With Partial-Onset Seizures

                Poster Session 1
                Review of Psychiatric and Behavioral Events in Perampanel
1.146           Clinical Studies

                Poster Session 1
                Pooled Perampanel Phase III Trials: Time to Onset and Duration
1.147           for Most Common Adverse Events

                Poster Session 1
                Evaluation of Abuse Potential of Perampanel
1.154
                Poster Session 1
                Efficacy and Safety of Adjunct Perampanel Based on Number of
                Antiepileptic Drugs at Baseline and Baseline Predictors of
1.230           Efficacy: Phase III Post-Hoc Analysis

                Poster Session 1
                Lesional vs. Non-lesional Partial Epilepsy: Post-hoc Analysis
2.048           of Pooled Perampanel Phase III Studies

                Poster Session 2
                Efficacy and Safety of Perampanel in Patients With Neurologic
                & Psychiatric Comorbidities: Post-hoc Analysis of Phase III
2.049           Epilepsy Trials

                Poster Session 2
                Analysis of Aggression in Perampanel Phase III Epilepsy
2.050           Clinical Trials

                Poster Session 2
                Effect of Ketoconazole on Perampanel Pharmacokinetics
2.063
                Poster Session 2
                Exploration of Adverse Events by Region, and Detailed Focus on
                Psychiatric Events, With Long-term Open-label Perampanel
2.148           Treatment

                Poster Session 2
                Long-term Retention, and Reasons for Discontinuations, With
3.211           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

  oSerious 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
  oThese reactions occurred in patients with and without prior psychiatric
    history, prior aggressive behavior, or concomitant use of medications
    associated with hostility and aggression
  oAdvise 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
  oClosely monitor patients particularly during the titration period and at
    higher doses
  oFYCOMPA 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.

Website: http://www.eisai.com
 
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