<P>To find out more information about FYCOMPA™, speak to your representative or go to FYCOMPA.com * Pooled results of three randomized, double-blind, placebo- controlled, multicenter trials of FYCOMPA. All trials had a 6-week baseline period followed by a 19-week treatment period (6 week titration + 13 week maintenance), and patients were required to have =5 seizures at baseline to be randomized.1, 4 • More than 85 of patients were taking 2-3 concomitant AEDs with or without concurrent VNS; approximately 50 were on at least one enzyme-inducing AED1 • Primary endpoint was the percent change in seizure frequency per 28 days during the treatment period as compared to the baseline period1 † Concomitant enzyme-inducing AEDs (carbamazepine, oxcarbazepine, or phenytoin) resulted in a substantial reduction in efficacy.1 ‡ Antiepileptic drugs One tablet, once-daily oral dosing at bedtime1 • Starting dosage is 2 mg once daily in patients not taking enzyme- inducing AEDs,‡ and 4 mg in patients taking enzyme-inducing AEDs • Increase dose based on clinical response and tolerability by a maximum of 2 mg once daily, no more frequently than every week, to a dose of 4 mg to 12 mg per day • A dose of 12 mg once daily resulted in somewhat greater reductions in seizure rates than the dose of 8 mg once daily, but with a substantial increase in adverse reactions NEW TARGET. NEW POTENTIAL. The first and only non-competitive AMPA receptor antagonist1-3 Adjunctive therapy for patients ages 12 and up with partial-onset seizures1 Demonstrated efficacy across all partial-onset seizures in clinical trials1* Without InducersWith Inducers† 4 mg/day 8 mg/day 12 mg/day 15 26 33 12 14 19 MEDIAN REDUCTION IN SEIZURE FREQUENCY FROM BASELINE (PLACEBO ADJUSTED) FYCOMPA™ is a trademark of Eisai R&D Management Co., Ltd., licensed to Eisai Inc. Manufactured and marketed by Eisai Inc., Woodcliff Lake, NJ 07677 © 2014 Eisai Inc. All rights reserved. FYCO0547 July 2014 Indication FYCOMPA (perampanel) is indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older. 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-treated 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-treated 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. Johns 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 ab used or lead to drug dependence. Please see Brief Summary of full Prescribing Information on the next page for Boxed WARNING and additional Important Safety Information. References: 1. Fycompa Prescribing Information. Woodcliff Lake, NJ: Eisai Inc.; October 2013. 2. Rogawski MA. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Curr. 2011;11:56-63. 3. Hanada T, Hashizume Y, Tokuhara N, et al. Fycompa: a novel, orally active, noncompetitive AMPA-receptor antagonist that reduces seizure activity in rodent models of epilepsy. Epilepsia. 2011;52:1331-1340. 4. Data on file. Eisai Inc., Woodcliff Lake, NJ; 2012. 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