Innovations In Clinical Neuroscience

Current Trends in Epilepsy 2015

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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76 % 100 80 60 40 20 Median Seizure Reduction (%) (n=81) (n=81) 38 76 P<0.0001 Primary Endpoint: Median Reduction in PGTC Seizure Frequency per 28 Days* FYCOMPA + 1 to 3 AEDs Placebo + 1 to 3 AEDs VISIT FYCOMPA.COM/HCP FOR MORE INFORMATION Please see Important Safety Information, including Boxed WARNING and Brief Summary of full Prescribing Information on following pages. References: 1. FYCOMPA Prescribing Information. Woodcliff Lake, NJ: Eisai Inc.; June 2015. 2. Data on fi le. Eisai Inc., Woodcliff Lake, NJ; 2015. FYCOMPA achieved a statistically signifi cant median reduction in PGTC seizure frequency 1 Phase 3 Study Design Multicenter, randomized, double-blind, placebo-controlled, parallel-group study on effectiveness of FYCOMPA as adjunctive therapy in patients 12 years of age and older. The total treatment period was 17 weeks (4: titration; 13: maintenance). Inclusion criteria included taking 1 to 3 concomitant AEDs at baseline and ≥3 PGTC seizures experienced in 8-week baseline period. 1 * Median percent change in PGTC seizure frequency during the treatment period as compared with the baseline period. † AEDs at baseline: lamotrigine, valproic acid/ergenyl chrono, levetiracetam, topiramate, zonisamide, clonazepam, carbamazepine, phenytoin, phenobarbital, clobazam, ethosuximide, oxcarbazepine, lacosamide, gabapentin, lorazepam, acetazolamide, clorazepic acid, mesuximide, sultiame, tiagabine. Change the Course of PGTC Seizure Treatment for Your Patients Experience the Strength of FYCOMPA ® ǩ 80% of patients were treated with 1 or 2 AEDs at baseline 2 ǩ 6 most commonly used concomitant AEDs at baseline: lamotrigine, valproic acid/ergenyl chrono, levetiracetam, topiramate, zonisamide 1† Adverse reactions in PGTC seizure study Dizziness (6% and 32%) Fatigue (6% and 15%) Headache (10% and 12%) Somnolence (4% and 11%) Irritability (2% and 11%) Vertigo (2% and 9%) Vomiting (2% and 9%) Weight gain (4% and 7%) Most frequently (≥4%) reported adverse reactions for placebo (n=82) and FYCOMPA 8 mg (n=81), respectively: Contusion (4% and 6%) Nausea (5% and 6%) Abdominal pain (1% and 5%) Anxiety (4% and 5%) Urinary tract infection (1% and 4%) Ligament sprain (0% and 4%) Balance disorder (1% and 4%) Rash (1% and 4%) For adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients 12 years of age and older

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