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    Home > Medical News > Medical Research Articles > Aishi submitted an application for a supplementary new drug in Japan for the anti-epileptic drug Fycompa ® (Verumpanai)

    Aishi submitted an application for a supplementary new drug in Japan for the anti-epileptic drug Fycompa ® (Verumpanai)

    • Last Update: 2020-06-10
    • Source: Internet
    • Author: User
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    recently, Aishi Corporation (hereinafter referred to as "Aisi") announced that it has submitted a supplementarynew drug(http://application for its exclusive anti-epileptic drug Fycompa ® (Verumpana) developed in Japan, with the intention of using it for the single-drug treatment of partial seizures of epilepsy, partial seizures in children 4 years and older, and the introduction of a new fine particle preparationThis single-drug application for partial seizures of epilepsy is based on the results of a Phase III clinical study (FREEDOM / 342 studies) conducted in Japan and South KoreaIn the "FREEDOM" study, the percentage of untreated epileptic partial seizures achieved without seizures after Fycompa single-drug treatment exceeded the therapeutic standard and reached the primary endpointthe most common adverse reactions observed in study 342 (incidence 10% or higher) were dizziness, drowsiness, nasopharyngitis and headaches, which is consistent with the safety data of Fycompa to dateThe application for the use of Fycompa to treat partial seizures in children is based on the results of a Phase III clinical study (311) conducted in Japan, the United States and Europe for the use of Fycompa in assisted therapy in the child patient sonThe 311 study assessed The partial seizure or primary all-round aggressive seizures of epilepsy that Fycompa had been treated in children (4 to 12 years old) with otherdrug(http://could not be fully controlled, confirming that Fycompa was essentially as safe and effective in children as in patients aged 12 and overIn addition, with regard to additional applications for fine particle formulations, Wesfarmers developed this formula to facilitate children and patients with difficulty taking tablets and to make Fycompa easier to takeThe application was subsequently submitted after a clinical study confirmed the bioequivalence of the formulation and the tablet formulationDetails of the "FREEDOM" study and the 311 study will be published at the(http://of the major academic conferences to be held thereafter
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