FDA Approves Eisai Inc. Drug for Epileptic Seizures

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WOODCLIFF LAKE, N.J., Oct. 22, 2012 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved FYCOMPA (perampanel) as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 and older. FYCOMPA is the first FDA-approved non-competitive AMPA glutamate receptor antagonist.

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"The FDA approval of FYCOMPA is an important development for the treatment of patients who continue to have seizures despite being on other prescription medications for epilepsy," said Lonnel Coats, President and Chief Executive Officer, Eisai Inc. "As a non-competitive AMPA glutamate receptor antagonist, FYCOMPA offers doctors and their patients a new approach towards seizure control."

FYCOMPA's approval was primarily based on three Phase III studies (304, 305 and 306), which were multi-center, randomized, double-blind, placebo-controlled, dose-escalation, parallel group studies to evaluate the efficacy and safety of perampanel 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) problems were also seen more frequently in patients treated with FYCOMPA. These reactions are described in the boxed warning bolded below.

The FDA has recommended that FYCOMPA be classified by the U.S. Drug Enforcement Administration (DEA) as a scheduled drug. The DEA will review the FDA's recommendation and determine the final scheduling designation. Once the DEA has provided the final scheduling designation, Eisai will announce when FYCOMPA will be available to patients and physicians in the United States.

Important Safety Information

Mental (psychiatric) Problems
FYCOMPA may cause new or worse aggressive behavior (including homicidal behavior), hostility, anger, anxiety, or irritability, being suspicious or distrustful (believing things that are not true) or other unusual or extreme changes in behavior or mood. Patients should call their healthcare provider right away if they have any new or worsening mental problems while taking FYCOMPA.

Suicidal Thoughts and Actions
Antiepileptic drugs, including FYCOMPA, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Patients should call their healthcare provider right away if they have any new or worsening symptoms of depression, any unusual or sudden changes in mood, feelings, behavior, or suicidal thoughts, behavior, or thoughts of self-harm that they have never had before or may be worse than before.

Dizziness, Vertigo (sense of spinning) and Problems Walking Normally
Patients may have problems walking normally if they are unsteady because they feel dizzy. These symptoms may increase when their dose of FYCOMPA is increased. A patient's risk of feeling dizzy and having problems walking normally may be higher if they are elderly.

Sleepiness and Tiredness
FYCOMPA may make a patient feel sleepy or tired. Patients should not drive, operate heavy machinery, or do other dangerous activities until they know how FYCOMPA affects them. A patient's risk of feeling sleepy and tired may be higher if they are elderly.

Taking FYCOMPA may increase a patient's chance of falling. These falls can cause serious injuries. A patient's risk of falling may be higher if they are elderly.

Withdrawal of AEDs
Patients must not stop FYCOMPA without first talking to their healthcare provider.Stopping FYCOMPA suddenly can cause serious problems and can cause patients to have seizures more often.

Drug Abuse and Dependence
FYCOMPA can be abused. Patients should tell their healthcare provider if they have abused prescription medicines, street drugs, or alcohol in the past. Physical dependence is characterized by withdrawal symptoms. The potential for FYCOMPA to produce withdrawal symptoms has not been adequately studied.

Pregnancy and Nursing
It is not known if FYCOMPA can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant while taking FYCOMPA. Patients and their healthcare providers will decide if they should take FYCOMPA while they are pregnant. If a patient becomes pregnant while taking FYCOMPA, she should talk to her healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (1-888-233-2334). It is not known if FYCOMPA passes into breast milk or if it can harm a baby. Patients should talk to their healthcare provider about the best way to feed their baby if they take FYCOMPA.

Liver and Kidney Problems
Patients should tell their healthcare provider if they have liver or kidney problems. They should not take FYCOMPA if they have severe kidney or liver problems.

Interactions with Other Medicines
Taking FYCOMPA with certain other medicines, such as birth control pills, carbamazepine, phenytoin, oxcarbazepine, rifampicin, and St. John's Wort, can cause side effects or reduce either drug's benefit. Patients should not drink alcohol or take other medicines that make them sleepy or dizzy while taking FYCOMPA until they talk to their healthcare provider. FYCOMPA taken with alcohol or medicines that cause sleepiness or dizziness may make their sleepiness or dizziness worse.

Most Common Adverse Reactions
In clinical trials, the most common adverse reactions seen in patients receiving FYCOMPA, were dizziness, sleepiness, tiredness, irritability, falls, nausea, problems with muscle coordination problems walking normally, vertigo and weight gain.

Please see the FYCOMPA 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 seizures. In about 25 to 30 percent of patients with epilepsy, seizures cannot be controlled with treatment.

Epilepsy is a therapeutic area of focus for Eisai. With the approval of FYCOMPA, Eisai 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 FYCOMPA (perampanel)
FYCOMPA is a once-daily, oral medication and the first FDA-approved non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor antagonist. AMPA receptors, widely present in almost all excitatory neurons, transmit signals stimulated by the excitatory neurotransmitter glutamate within the brain. Glutamate is the primary excitatory neurotransmitter in the central nervous system.

Discovered and developed by Eisai, FYCOMPA has been approved by Iceland, Norway and the European Commission on behalf of its 27 sovereign member states.

About Eisai Inc.
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since that time, Eisai Inc. has rapidly grown to become a fully integrated pharmaceutical business. Eisai's key areas of commercial focus are neurology and oncology. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com/US.

SOURCE Eisai Inc.

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