Eisai has presented the results of its Phase III pivotal study into the investigational compound perampanel as a treatment of partial-onset seizures.
Perampanel, discovered and developed by Eisai, is a highly selective non-competitive AMPA-type glutamate receptor antagonist.
The study involved 389 people who received either 8mg or 12mg of perampanel or placebo once-daily for 19 weeks in addition to regular treatment.
The primary and secondary endpoints were standard median per cent seizure reduction, 50% responder rate, percentage reduction of complex partial plus secondarily generalised seizures and evaluation for dose response.
The study results showed that perampanel 8mg once-daily reduced median seizure frequency by 30.5%, while perampanel 12 mgonce-daily reduced median seizure frequency by 17.6%. The placebo caused a reduction of 9.7%.
Response rates were 14.7% for the placebo, 33.3% for the 8mg dose and 33.9% for the 12mg dose.
Lynn Kramer, president of Eisai’s neuroscience product creation unit, said that the study demonstrated the statistical and clinical efficacy of perampanel for reducing partial-onset seizures among epilepsy patients.
