Add-on therapy with Fycompa (perampanel) is safe and effective in preventing seizures in adolescents with treatment-resistant refractory epilepsy, according to a real-world retrospective study from Taiwan.
The study, “Efficacy and tolerability of perampanel in children and adolescents with pharmacoresistant epilepsy: The first real-world evaluation in Asian pediatric neurology clinics,” was published in Epilepsy & Behavior.
Fycompa, developed by Eisai biopharma, is a highly selective inhibitor of AMPA receptors. These receptors are involved in the fast communication pathways between nerve cells in the central nervous system.
This compound has been widely approved as an add-on treatment for focal seizures — those that affect only one side of the brain — with or without secondary generalized seizures, and for primary generalized tonic-clonic seizures (normally referred to as convulsions) in patients with epilepsy ages 12 and older.
The safety and effectiveness of the compound in the pediatric population was demonstrated in three Phase 3 clinical studies (NCT00699972, NCT00699582, and NCT00700310), and an extension study (NCT00735397).
But there’s been little information on the safety and effectiveness of Fycompa in the real-world clinical setting with a diverse patient population.
Researchers reviewed the clinical records of 66 children and adolescents with refractory epilepsy whose seizures were resistant to more than two antiepileptic drugs, and could be followed up for a minimum of three months after they began taking Fycompa adjunctive therapy.
Among the participants, six had been diagnosed with Lennox-Gastaut syndrome, five had Dravet syndrome, three had juvenile myoclonic epilepsy, and one had progressive myoclonic epilepsy.
All participants were followed in the Department of Pediatric Neurology of Chang Gung Children’s Hospital in Taiwan.
A reduction in seizure frequency of more than 50% was observed in 30.3% of patients after three months; 37.5% of patients after six months; and 34.7% of patients after 12 months of Fycompa add-on treatment.
Also during these time points, 7.6% of patients became seizure-free after three months; 8.9% became seizure-free after six months; and 14.3% were seizure-free after a year.
Among Dravet syndrome patients, four experienced a 50% seizure reduction at the last visit (12 months), at which point two of them were seizure-free and one patient had a 75-99% reduction in seizure frequency.
During the study, 25 patients reported adverse reactions, which led to Fycompa discontinuation in eight cases. The most common adverse events included irritability, skin rash, dizziness, and somnolence. All cases were transient and successfully managed after a dose reduction of Fycompa or patients discontinued treatment.
Based on these real-world data, researchers believe Fycompa is an effective and tolerable therapy for “the treatment of pharmacoresistant epilepsy in pediatric patients,” with an important role in clinical practice.
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