Eisai has announced positive Phase III trial results of investigational compound perampanel (E2007), a first-in-class, highly selective and non-competitive AMPA-type glutamate receptor antagonist to treat partial seizures in epilepsy patients.
The study was double-blind, parallel-group and placebo-controlled. It involved 706 patients from 25 countries, who were randomised to receive the placebo or one of the three perampanel doses (2mg, 4mg or 8mg).
The study showed that perampanel was well-tolerated and effective in reducing median seizure frequency and increasing responder rates, the primary outcome measures in the US and European Union respectively.
The findings were highly statistically significant for the 4mg and 8mg doses compared to the placebo, and a linear trend in dose response was also statistically significant.
Dizziness, headache and somnolence were the most common adverse events reported.
Two more Phase III trials of perampanel are currently underway.
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