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news.Swissmedic, the Swiss Agency for Therapeutic Products, has accepted to review Eisai's perampanel as a treatment for partial-onset seizures in patients with epilepsy.
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Perampanel is a highly selective, non-competitive a-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA)-type glutamate receptor antagonist that has demonstrated anti-epileptic effects in Phase II and III studies.
The clinical development plan for perampanel consisted of three global Phase III studies: Studies 306, 305 and 304 in which a total of 1,480 patients participated.
The goal of study 306 was to identify the minimal effective dose and included four treatment arms (placebo, 2mg, 4mg, and 8mg).
Studies 304 and 305 included three arms (placebo, 8mg, and 12mg) and were to evaluate a more extended dose range.
Eisai Europe EU Epilepsy Business Unit head Bettina Bauer said the acceptance by Swissmedic to review perampanel for use in Switzerland is a positive step forward in the approval process.