In a phase 3 study, perampanel (Fycompa; Eisai, Woodcliff Lake, NJ) used as monotherapy for new-onset or untreated partial-onset seizures (POS) provided seizure freedom for 63% (46/73) of people treated (95% CI: 50.9–74.0). In an open-label descriptive study (NCT03201900), 73 participants, age 12 years or more, were treated with 4 mg/day of perampanel after a 6-week titration period and a 4-week pretreatment phase. Participants’ median baseline seizure frequency before treatment was 2 seizures/12 weeks. Of the patients who had secondarily generalized seizures, 65% (31/48) did not have convulsive seizures during the study. Adverse events that occurred in more than 5% of participants included dizziness (26.5%), nasopharyngitis (13.2%), somnolence (13.2%) and headache (10.3%).
These data were presented by Takamichi Yamamoto, MD, MS, DMSc, FAES, vice executive director and neurosurgeon at Seirei Hamamatsu General Hospital at the 33rd International Epilepsy Congress in Bangkok.
“Through research and development of compounds in our epilepsy franchise, Eisai is committed to shifting the conversation from seizure control to seizure freedom whenever possible. Results from this first investigation of Fycompa as monotherapy in patients with POS are an example of this shift,” said Lynn Kramer, MD, chief clinical officer and chief medical officer, Neurology Business Group, Eisai, “Data from the FREEDOM study showed a seizure freedom rate of 63% with a 4mg/day dose of FYCOMPA as monotherapy in newly diagnosed or untreated patients with POS.”
“When selecting an antiepileptic drug for my patients, I consider benefits of single pill dosing which can reduce overall pill burden, hopefully making it easier for patients to adhere to their treatment schedule as early as possible while taking into account tolerability,” said James Wheless, MD, chair at the Division of Pediatric Neurology, Le Bonheur Children's Hospital, Memphis, Tennessee. “I am excited to see monotherapy data in newly diagnosed patients. In the FREEDOM study, the majority of patients taking 4 mg/day of FYCOMPA achieved convulsive seizure freedom during the 26-week period.”
Perampanel is noncompetitive selective AMPA receptor antagonist approved for monotherapy and adjunctive use in people age 4 years or more for the treatment of POS with or without secondarily generalized seizures. and as adjunctive therapy for generalized tonic-clonic seizures in people age 12 years or more and has been used to treat more than 200,000 patients worldwide across all indications.