Eisai Announces U.S. Availability of FYCOMPA™ (perampanel) CIII an Adjunctive Treatment for Partial-Onset Seizures in Patients

Eisai Announces U.S. Availability of FYCOMPA™ (perampanel) CIII an Adjunctive
  Treatment for Partial-Onset Seizures in Patients with Epilepsy Age 12 and
                                    Older

FYCOMPA is the First and Only FDA-Approved Non-Competitive AMPA Glutamate
Receptor Antagonist

PR Newswire

WOODCLIFF LAKE, N.J., Jan. 2, 2014

WOODCLIFF LAKE, N.J., Jan. 2, 2014 /PRNewswire/ --Eisai Inc. announced today
that FYCOMPA™ (perampanel) CIII will be available to eligible patients by
prescription in the U.S. beginning January 6, 2014. FYCOMPA is an adjunctive
therapy for the treatment of partial-onset seizures with or without
secondarily generalized seizures in patients with epilepsy age 12 years and
older. FYCOMPA is the first non-competitive AMPA glutamate receptor antagonist
to be approved by the FDA. 

To view the multimedia assets associated with this release, please click:
http://www.multivu.com/mnr/64835-eisai-fycompa-perampanel-ciii-adjunctive-treatment-partial-onset-seizures

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"FYCOMPA offers patients and their physicians a new adjunctive treatment
option," said Lonnel Coats, President and Chief Executive Officer, Eisai Inc.
"This is important because far too many patients with partial onset seizures
continue to have seizures even while on medication."

FYCOMPA was approved by the FDA in October 2012, primarily based on three
Phase III studies (304, 305 and 306). These multi-center, randomized,
double-blind, placebo-controlled, parallel group studies evaluated the
efficacy and safety of FYCOMPA compared to placebo given as adjunctive therapy
in patients age 12 and older with partial-onset seizures. The studies
demonstrated that FYCOMPA significantly reduced seizure frequency in patients
with partial-onset seizures with or without secondarily generalized seizures.

In the three clinical studies, the most common adverse events (greater than or
equal to 4 percent and greater than placebo) in patients treated with FYCOMPA
8 or 12 mg were dizziness, sleepiness, tiredness, irritability, falls, nausea,
problems with muscle coordination, problems walking normally, vertigo and
weight gain. Serious or life-threatening psychiatric (mental) and behavioral
problems were also seen more frequently in patients treated with FYCOMPA.
These reactions are described in the Boxed WARNING bolded below and the
Important Safety Information.

"We found that these Phase III studies showed a significant reduction in the
number of partial-onset seizures in patients that had FYCOMPA added to their
treatment regimen," said Lynn Kramer, MD, FAAN, President, Neuroscience &
General Medicine, Eisai Product Creation Systems. "The availability of FYCOMPA
gives physicians an important new adjunctive treatment option for the care of
those patients whose seizures are not controlled by their current medication."

FYCOMPA has been designated by the U.S. Drug Enforcement Administration as a
federally controlled substance (CIII).

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 (greater than
or equal to 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

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. The precise mechanism by which FYCOMPA exerts its
antiepileptic effects in humans has not been fully elucidated.

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

FYCOMPA will be supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg
film-coated tablets.

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.

Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to
patients and their families. As the U.S. pharmaceutical subsidiary of
Tokyo-based Eisai Co., Ltd., our passionate commitment to patient care is the
driving force. 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



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FYCOMPA(TM) (perampanel) CIII will be supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10
mg and 12 mg film-coated tablets.



FYCOMPA(TM) (perampanel) CIII

To view the multimedia assets associated with this release, please click:
http://www.multivu.com/mnr/64835-eisai-fycompa-perampanel-ciii-adjunctive-treatment-partial-onset-seizures

SOURCE Eisai Inc.

Website: http://www.eisai.com
 
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