Positive results in two Phase III studies of Fycompa (Eisai) for Epilepsy

Results from the final pivotal Phase III study and long term Phase III extension study of Epilepsy drug Fycompa (perampanel), from Eisai, have been published online in Epilepsia. Findings from Study 305, one of three pivotal global studies, and the extension study for perampanel add further weight to the growing body of clinical evidence supporting the efficacy and safety of the new treatment.

The 305 study demonstrated that once-daily, adjunctive perampanel improved seizure control and was acceptably-tolerated in subjects 12 years and older with refractory partial-onset seizures. Study 305 is one of three pivotal Phase III studies in the EXPLORE clinical trial programme.

The 307 interim results showed that perampanel had an acceptable tolerability profile in patients with refractory partial-onset seizures over the longer term. Furthermore, reduced seizure frequency and improved responder rates were consistent and maintained during 1 - 2 years of continued perampanel therapy. Study 307 is an open-label extension study for people with epilepsy completing the double-blind phase of three pivotal Phase III trials (studies 304, 305, and 306).

The marketing authorization application for perampanel is currently under review with the FDA. See: "Perampanel, a selective, noncompetitive ?-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor antagonist, as adjunctive therapy for refractory partial-onset seizures: Interim results from phase III, extension study 307." Gregory L. Krauss et al. and "Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: Results of randomized global phase III study 305" Jacqueline A. French et al. Epilepsia 20 AUG 2012.