Phase 3 Study of Perampanel for Seizures

Eisai Inc. announced results from its Phase 3 study of perampanel for the treatment of partial-onset seizures. Study 305, the final of three Phase 3 studies in the EXPLORE (EXamining Perampanel Observations from Research Experience) clinical trial program, was a global randomized, double-blind, placebo-controlled, dose-escalation, parallel group study in which 389 epilepsy patients participated. Participants received either 8mg or 12mg of perampanel or placebo once daily for 19 weeks in addition to their regular treatment. Median seizure frequency was the primary outcome measure in the U.S.

Results of Study 305 demonstrated the statistical and clinical efficacy of perampanel for reducing partial-onset seizures among epilepsy patients. Response rates (defined as ≥50% reduction in seizure frequency) were 14.7% for placebo, 33.3% for 8mg (P=0.002) and 33.9% for 12 mg (P=<0.001). Study results also showed that perampanel 8mg once-daily reduced median seizure frequency by 30.5% (P=0.001) and perampanel 12mg once-daily reduced median seizure frequency by 17.6% (P=0.0011) vs. placebo (9.7%) among patients receiving treatment with one to three other epilepsy drugs.

Perampanel is a highly selective non-competitive AMPA-type glutamate receptor antagonist that is orally administered.

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