Eisai announced that the Food and Drug Administration has accepted the supplemental New Drug Application (sNDA) for Priority Review for Fycompa (perampanel) as monotherapy and adjunctive therapy in the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures, in addition to adjunctive use for primary generalized tonic-clonic (PGTC) seizures in pediatric patients with epilepsy (2 to <12 years old).
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 primary objective of safety and tolerability was measured by incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), laboratory parameters, vital signs, and ECG parameters.
Findings from Study 232, an open-label pilot study with an extension phase, were also included. The study evaluated the pharmacokinetics and gathered preliminary data on safety, tolerability, and efficacy of Fycompa oral suspension as adjunctive therapy in patients aged 2 to <12 years with epilepsy.
“The incidence of seizures in the pediatric age group has been steadily increasing in the US where an estimated 470,000 children are living with epilepsy today. Approximately 30 percent of all patients have uncontrolled seizures, and it is crucial that we do whatever we can to help these patients achieve the ultimate goal of seizure freedom,” said Trevor Resnick, MD, Pediatric Neurologist at Nicklaus Children’s Hospital. “Approximately 71 percent of all people living with epilepsy miss at least one dose of their medication per month, and 45 percent of those missed doses result in a subsequent breakthrough seizure. Fycompa’s long, 105 hour half-life may play an important role for patients who miss doses.”
Fycompa, an AMPA glutamate receptor antagonist, is currently approved for POS (monotherapy or adjunctive therapy) with or without secondarily generalized seizures in patients with epilepsy ≥12 years old, and as adjunctive therapy for PGTC seizures in patients with epilepsy aged ≥12 years. It is available in 2mg, 4mg, 6mg, 8mg, 10mg, 12mg tablets and a 0.5mg/mL oral suspension.
For more information call (888) 422-4743 or visit Fycompa.com.