A supplemental new drug application (sNDA) has been submitted seeking priority review for the use of perampanel (CIII) (FYCOMPA; Eisai Inc, Woodcliff Lake, NJ) for specific pediatric indications. Perampanel is an oral formulation of a selective, noncompetitive blocker of the AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor ion channel; it is approved for treating partial onset seizures (POS) as monotherapy or for primary generalized tonic-clonic (PGTC) seizures as adjunct therapy in people with epilepsy aged 12 and older. Perampanel has been designated by the Drug Enforcement Administration as a federally-controlled substance (CIII) because there is a potential for abuse and addiction.
The supplemental approval is for treatment of POS and of PGTC as either monotherapy or adjunctive therapy in children aged 2 to 12 years with epilepsy. The request for approval is based upon a 2018 draft guidance from the FDA regarding clinical development programs that can support extrapolation of the effectiveness of drugs approved for POS to pediatric patients, which was based upon the similarity of POS in adults and children aged at least 4 years with epilepsy, as well as the similar dose-response curves for many antiepileptic drugs in pediatric and adult patients with POS. The sNDA includes interim data from an ongoing global open-label, multicenter study (Study 311) with an extension phase. The primary objective of Study 311 was to establish safety and tolerability of perampanel in children ages 4-11 with inadequately controlled seizures. The study also measured the efficacy of perampanel as measured by the median percent change in seizure frequency for a 28-day period of responders by quartile. Effects of perampanel on cognition, behavior, visuomotor skills, and growth and development were also assessed. In addition, data from Study 232, an open-label pilot study with extension phase that evaluates pharmacokinetics, safety, and tolerability of perampanel when given as adjunctive therapy to patients with epilepsy ages 2 to 12 years.
Jesus Eric Piña-Garza, MD, Pediatric Neurologist, Tri-Star Medical Group Children's Specialists stated, "FYCOMPA's long, 105-hour half-life and unique mechanism of action may benefit young patients and their physicians looking for a new mono- or adjunctive therapy option as they continue toward their goals of reaching seizure freedom."Next Story