The sNDA included data from Study 311 (N=180), an ongoing, open-label, multicenter trial with an extension phase that evaluated the safety, tolerability, and exposure-efficacy relationship of Fycompa oral suspension as adjunctive therapy in children (4 to 11 years) with inadequately controlled POS or PGTC seizures.
The expanded approval was supported by extrapolated efficacy data from placebo-controlled studies in adults with partial-onset seizures.
Epidiolex added to other antiepileptic therapies significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome.
The proposed pediatric indications are based on a 2018 Draft Guidance that supports extrapolating efficacy data of approved drugs to treat POS in adults to pediatric patients aged ≥4 years.
New research suggests that the antiepileptic drug (AED) topiramate, when used in combination with other AEDs (excluding valproate) may enhance its propensity to cause fetal malformation.
(HealthDay News) — Cannabidiol might benefit some children with epilepsy whose seizures aren't controlled by approved medications, according to research scheduled to be presented at the annual meeting of the American Epilepsy Society, held from December 4 to 8 in Philadelphia.