Positive final pivotal Ph III results for Eisai's Fycompa

Results from the final pivotal Phase III study and long term Phase III extension study of Japanese drug major Eisai’s (TYP: 4523) epilepsy drug Fycompa (perampanel), were published on-line yesterday in Epilepsia. Findings from Study 305, one of three pivotal global trials 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 company said.

Perampanel, which was approved by the European Commission last month (The Pharma Letter July 3) and is set to launch in Europe next month, is the only licensed anti-epileptic drug in Europe that selectively targets AMPA receptors, which are thought to play a central role in seizure generation and spread. This first in class treatment selectively targets the transmission of seizures by blocking the effects of glutamate, which can trigger and maintain seizures.

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 (EXamining PerampaneL Observations from Research Experience) clinical trial program.