Eisai has reported positive results from a Phase III clinical trial of perampanel in epilepsy, and the drug remains on track for submission to regulators around the globe in 2011.
The drugmaker said a double-blind, placebo-controlled, parallel-group study (Study 306) showed that perampanel (E2007) was well-tolerated and effective in reducing median seizure frequency and increasing responder rates versus placebo.
Specific results of the trial – the first in the drug’s Phase III programme for epilepsy –were not revealed at this point, but the firm did say that statistically significant differences were seen in patients given 4mg and 8mg doses compared to those on placebo, and that the most common side effects reported were dizziness, somnolence and headache.
Two further Phase III studies assessing perampanel - a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist - as adjunctive treatment of partial seizures are currently underway, with results expected within a year, and Eisai reiterated its plans to file for approval next year.
News of perampanel’s success will be especially sweet for the firm as it was forced to terminate the drug’s development programme in Parkinson’s disease in 2008, after it failed to hit targets in clinical trials.