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Eisai Co Ltd Announces Final Pivotal Phase III Fycompa (perampanel) Study Results Published Ahead of First European Launch


Tuesday, 31 Jul 2012 07:02pm EDT 

Eisai Co Ltd announced results from the final pivotal Phase III study and long term Phase III extension study Fycompa (perampanel), were 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 (EXamining PerampaneL Observations from Research Experience) clinical trial programme. Showing consistency with other results from the Phase III clinical trial programmes, 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.[2] 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). 

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