Eisai launches new epilepsy drug in Russia

Eisai announced on June 9 that it will launch a new generation of epilepsy drug Fycompa (perampanel) in Russia. It will be used to assist partial epileptic seizures (with or without secondary generalized seizures) in adults aged 12 and over. treatment.

The approval of Fycompa in Russia was based on data from three randomized, double-blind, placebo-controlled, dose-escalation global key phase III studies (304, 305, 306) and an open-label extension study (307). Three phase III studies have demonstrated the efficacy and good tolerability of perampanel in the adjuvant treatment of partial seizures. Open-label extension studies demonstrate long-term efficacy and good tolerability of perampanel. The most common adverse events reported by the Institute included dizziness, headache, lethargy, irritability, fatigue, and ataxia.

Founded and developed by Eisai, Fycompa is a highly selective and non-competitive AMPA glutamate receptor antagonist. Glutamate is the main neurotransmitter that mediates seizures. As an AMPA receptor antagonist, Fycompa can reduce hyperactivity of seizure-related neurons by targeting postsynaptic AMPA receptor-glutamate activity. This mechanism of action is different from the currently available antiepileptic drugs (AEDs), which means that Fycompa is the first AED drug in this class of new drugs that has been approved by the European Union for the treatment of adults and adolescents older than 12 years of age.

Fycompa has the benefits of a once-daily serving, which is expected to reduce the potential medication burden and improve patient compliance.

Epilepsy is one of the most common diseases of the nervous system in the world. In Russia, the incidence of epilepsy is 3/1000, and approximately 82% of patients have partial (focal) epilepsy. Seizures are the result of brain neurons firing and suppression of imbalances. These imbalances may be triggered by multiple neurochemical mechanisms, but little is known at present.