Fycompa sNDA Submitted for Pediatric Seizure Indications
The sNDA contains interim data from Study 311, a global, open-label, multicenter study of 180 patients
Eisai announced the submission of its supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Fycompa (perampanel) tablets and oral suspension. The sNDA is intends to widen the treatment indication as a monotherapy and adjunctive in partial-onset seizures (POS) with or without secondarily generalized seizures for children aged 2–<12 years. Also, the Company is seeking a pediatric indication for Fycompa as monotherapy and adjunctive use for primary generalized tonic-clonic seizures (PGTC) in children aged 2–<12 years with epilepsy.
Fycompa, an AMPA glutamate receptor antagonist, is already approved to treat POS with or without secondarily generalized seizures in patients with epilepsy aged ≥12 years, and as adjunctive therapy for PGTC seizures in patients with epilepsy aged ≥12 years.
The proposed pediatric indications are based on a 2018 Draft Guidance that supports extrapolating efficacy data of approved drugs to treat POS in adults to pediatric patients aged ≥4 years. The sNDA contains interim data from Study 311, a global, open-label, multicenter study (N=180) with an extension phase. The study evaluated safety, tolerability, and exposure-efficacy relationship of Fycompa oral suspension when given as an adjunctive in 4–11 year-olds with inadequately controlled POS or PGTC seizures.
The primary objective was safety and tolerability, as measured by incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), laboratory parameters, vital signs, and ECG parameters.
Data from Study 232, an open-label pilot study with an extension phase were also included in the sNDA. The study aimed to evaluate safety, tolerability, and efficacy of Fycompa oral suspension when given as adjunctive therapy in patients aged 2–<12 years with epilepsy.
Fycompa, a CIII controlled substance, is available as 2mg, 4mg, 6mg, 8mg, 10mg, and 12mg strength tablets as well as a 0.5mg/mL strength oral suspension.
For more information call (888) 422-4743 or visit Fycompa.com.