Fycompa meets Phase III trial endpoint in seizures trial

Top-line results show the primary efficacy endpoint was met in a Phase III clinical study (Study 342) conducted for submission in Japan, which evaluated antiepileptic drug (AED) Fycompa (perampanel) as monotherapy for partial-onset seizures.

Based on the results of this study, Japanese pharma major Eisai (TYO: 4523) plans to file an application seeking approval of in-house developed Fycompa as monotherapy for partial onset seizures in Japan during fiscal 2018, with the news sending the firm’s share up 2.58% to 10,125 yen by close of trading today.

Study 342 is a multicenter, open-label, single-arm Phase III clinical study for verification of efficacy and safety for Fycompa monotherapy in untreated patients from 12 to 74 years of age with partial onset seizures, and compared this efficacy and safety with the results from other AED monotherapy studies. The primary efficacy endpoint of the study is the percentage of patients who achieved seizure-free during the maintenance period (26 weeks of treatment administration) of 4 mg/day of Fycompa. From the results of this study, the percentage of patients who achieved seizure-free exceeded the criteria for efficacy, and the primary endpoint was met.

The most common adverse events (incidence of 10% or higher) observed in Study 342 were dizziness, somnolence, nasopharyngitis and headache, which is consistent with the safety profile of Fycompa to date.

Eisai considers neurology including epilepsy, a therapeutic area of focus, and in continued pursuit of its mission to provide "seizure freedom" to a greater number of patients living with epilepsy. Eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

Fycompa is currently approved in more than 55 countries and territories, including the USA, Japan, in Europe and in Asia as adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older. In Japan, Fycompa is approved as an adjunctive therapy for partial-onset seizures (including secondarily generalized seizures) or primary generalized tonic-clonic seizures in patients with epilepsy showing inadequate response to other AEDs.