An analysis of efficacy and safety outcomes in patients receiving perampanel as first adjunctive antiepileptic drug found that almost half of the patients were seizure-free.
Perampanel (Fycompa) was found to be effective in seizure control and response with a favorable tolerability outcome regardless of the first-line concomitant antiepileptic drug (AED) at baseline in patients older than 12 years with partial-onset seizures (POS), with or without secondary generalized seizures (SGS).
“These data support the use of perampanel as first adjunctive therapy in patients with POS, with or without SGS, regardless of the first-line AED,” said Manoj Malhorta, MD, head of Medical Affairs for Eisai US in a press release.
Results were based off the FAME study, a multicenter, open-label, single-arm, phase 4 trial conducted in South Korea. The study investigated the efficacy and safety of perampanel as the first adjunctive therapy in patients ≥12 years with POS, with or without SGS.
The findings were presented at the 2019 American Epilepsy Society Annual Meeting in Baltimore, MD.
Researchers presented a post-hoc subgroup analysis of efficacy and safety outcomes in patients receiving perampanel as first adjunctive AED with different first-line AEDs. The study consisted of an 8-week screening period, a 12-week titration period, and a 24-week maintenance period.
This study included 85 participants with POS, of which 16 had SGS. The average age was 42 years. All 85 participants received a concomitant AED of levetiracetam, carbamazepine, oxcarbazepine, lamotrigine, valproic acid, topiramate, or zonisamide. The primary endpoint was the 50% responder rate, or the proportion of patients achieving a greater than or equal to 50% reduction in seizure frequency from baseline during maintenance. Secondary endpoints included seizure-freedom rate and median percent change in seizure frequency per 28 days.
According to a press release, 47% (40/85) of patients were seizure-free and required adjunctive therapy after failure to control POS with 1 AED. The 50% responder rate was 80% (68/85) and the 75% responder rate was 71.8% (61/85). This post-hoc analysis shows favorable efficacy and tolerability of adjunctive perampanel in patients aged ≥12 years with POS, with or without SGS, regardless of the first-line concomitant AED used at baseline, according to Malhorta.
“The study was limited by the inclusion of only Korean patients, the open-label and non-randomized design, the absence of a comparator, and only a relatively small number of patients were included. However, it followed a comprehensive clinical development program that was conducted worldwide, with several other studies already indicating the efficacy and safety of perampanel in treatment-refractory patients,” Malhorta said.
In September 2018, perampanel was approved for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of POS with or without SGS. Perampanel was first approved in 2012 for adjunctive use in POS in patients 12 years and older.
In 2015, it was approved as adjunctive therapy for PGTC seizures in patients with epilepsy 12 years and older. To date, perampanel is approved in 55 countries and has been used to treat more than 200,000 patients worldwide across all indications.