WOODCLIFF LAKE, N.J., June 22, 2015 /PRNewswire/ -- Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved FYCOMPA^® (perampanel) CIII for adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures, one of the most common and severe forms of generalized seizures with a high incidence of morbidity and mortality.

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The approval of the new indication was based on a Phase 3, randomized, double-blind, placebo-controlled clinical trial (Study 332) of 162 patients, taking one to three antiepileptic drugs, evaluating the efficacy and safety of FYCOMPA as adjunctive therapy for PGTC seizures in patients 12 and older. The study demonstrated that patients treated with FYCOMPA (n=81) achieved a 76% median reduction in PGTC seizure frequency, which was statistically significant compared to 38% with placebo (n=81). Additionally, 64% of patients treated with FYCOMPA experienced a 50% or greater reduction in PGTC seizure frequency versus 40% with placebo, which was also statistically significant.

The most frequently reported adverse events (>10% in the FYCOMPA group and greater than placebo) in patients treated with FYCOMPA in the Phase 3 clinical trial were dizziness, fatigue, headache, somnolence and irritability. The adverse event profile was similar to that noted in the controlled Phase 3 partial-onset seizure trials.

"For patients with PGTC seizures, treatment options are limited," said Steve S. Chung, M.D., Executive Director and Chair, Neuroscience Institute at the Banner University Medical Center in Phoenix, AZ and clinical trial investigator. "There is an unmet medical need among patients whose seizures are inadequately controlled with their current treatment and, with this indication, FYCOMPA may provide a new option for this group."

"The approval of FYCOMPA to treat patients age 12 and older with PGTC seizures represents an important next step toward expanding treatment options for patients whose PGTC seizures are not adequately controlled with their current medication," said Lynn Kramer, M.D., Chief Clinical Officer, Eisai Co. Ltd. and President of the Neuroscience & General Medicine Product Creation Unit. "Eisai is committed to advancing epilepsy care and making 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

FYCOMPA (perampanel) is indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.

FYCOMPA is an oral medication and the first and only FDA-approved non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor antagonist. The precise mechanism by which FYCOMPA exerts its antiepileptic effects in humans has not been fully elucidated.

FYCOMPA is supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets. FYCOMPA has been designated by the U.S. Drug Enforcement Administration as a federally-controlled substance (CIII).

FYCOMPA, approved in over 40 countries and currently available in 22 countries, was discovered and developed by Eisai. Over 35,000 patients globally have been treated with FYCOMPA.

To assist patients with access to their medication, Eisai offers eligible patients a FYCOMPA Savings Card.* Patients can register now at Fycompa.com to activate their savings card, if their doctor has already given them one, or download a card and print it at home.

*Restrictions apply. Not available to patients enrolled in federal or state healthcare program, including Medicare, Medicaid, Medigap, VA, DoD or TRICARE.

Please refer to complete Eligibility Criteria.

Please visit Fycompa.com to learn more about the treatment.

Important Safety Information

Serious Psychiatric and Behavioral Reactions

In the partial- onset clinical trials, 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. Homicidal ideation and/or threat have also been reported postmarketing in patients treated with FYCOMPA. 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. Similar serious psychiatric and behavioral events were observed in the primary generalized tonic-clonic seizure clinical trial.

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 in the partial-onset seizures clinical trials 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 in the partial-onset seizures clinical trials 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. These adverse reactions were also observed in the primary generalized tonic-clonic seizure clinical trial.

Somnolence and Fatigue

FYCOMPA caused dose-dependent increases in somnolence and fatigue-related events. Somnolence was reported in 16% and 18% of patients in the partial-onset seizures trials 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 in the partial-onset seizures trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 5% of placebo patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the primary generalized tonic-clonic seizure clinical trial. 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 in the partial-onset seizures clinical trials 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, but if withdrawal is a response to adverse events, prompt withdrawal can be considered.

Most Common Adverse Reactions

The most common adverse reactions (>5% and >1% higher than placebo) include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety.

Drug Interactions

FYCOMPA may decrease the efficacy of contraceptives containing levonorgestrel. Plasma levels of FYCOMPA were decreased when administered with carbamazepine, phenytoin, or oxcarbazepine. Concomitant use with strong CYP3A inducers such as St. John's wort or 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 Full Prescribing Information.

About Epilepsy and Primary Generalized Tonic-Clonic (PGTC) Seizures

Epilepsy affects 2.9 million people in the United States. Generalized seizures account for approximately 40% of all epilepsy, and PGTC seizures are one of the most common and severe forms of generalized seizures that frequently lead to morbidity and mortality. In about 30% of patients with epilepsy, seizures may not be adequately controlled with treatment.

For the majority of patients, a PGTC seizure begins with a loss of consciousness without any prior warning symptoms and a sudden contraction of the muscles, causing the patient to fall down (tonic phase). This is followed by violent convulsions (clonic phase) until the muscles finally relax, and the patient is left with a disturbance of consciousness. While the seizure generally only lasts a few minutes, the patient often feels confused, groggy or drowsy for a longer period of time before returning to normal.

About Eisai Inc.

At Eisai Inc., human health care (hhc) 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.

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Eisai Inc.
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Eisai Inc.
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