Eisai Completes Phase III Trial For Epilepsy Drug

The Phase III clinical trial for Eisai’s in-house developed AMPA receptor antagonist Fycompa® has met its primary endpoints in patients with severe seizures.

AsianScientist (Jun 26, 2014) – Eisai Co., Ltd., a pharmaceutical firm headquartered in Toyko, has concluded a Phase III clinical trial of its in-house-discovered AMPA receptor antagonist Fycompa® in patients with primary generalized tonic-clonic (PGTC) seizures, one of the most severe forms of generalized seizures.

The study was a double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive Fycompa therapy in 164 patients aged 12 years and older with uncontrolled PGTC seizures receiving one to a maximum of three anti-epileptic drugs.

Patients were randomized to receive Fycompa or placebo in a 1:1 ratio. Analysis of the study demonstrates that Fycompa significantly reduced PGTC seizure frequency and improved responder rates (the percentage of patients who experienced a 50 percent or greater reduction in PGTC seizure frequency) when compared to placebo. In this study, the most common adverse events were dizziness, fatigue, headache, irritability and somnolence. The adverse event profile observed in the study was similar to that observed in other studies with Fycompa.

Based on the results of this study, Eisai plans to submit applications during the first half of fiscal 2014 to health authorities in the EU and the U.S. for an indication expansion to include the adjunctive treatment of PGTC seizures. Furthermore, a clinical study on patients with partial-onset seizures is currently underway in Asia (including Japan), and Eisai plans to submit regulatory applications in Japan based on both of these studies in fiscal 2015.

Fycompa is a first-in-class anti-epilepsy drug discovered and developed by Eisai. Epileptic seizures are primarily mediated by the neurotransmitter glutamate. Fycompa is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.

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Source: Eisai.
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