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A small registrational trial of FIRDAPSE® (amifampridine) Tablets for the treatment of Lambert-Eaton myasthenic syndrome

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Trial Profile

A small registrational trial of FIRDAPSE® (amifampridine) Tablets for the treatment of Lambert-Eaton myasthenic syndrome

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Dec 2023

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At a glance

  • Drugs Amifampridine (Primary)
  • Indications Lambert-Eaton myasthenic syndrome
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 18 Dec 2023 According to a Catalyst Pharmaceuticals media release, DyDo Pharma, reported that it has submitted a New Drug Application to Japan's Pharmaceuticals and Medical Devices Agency seeking marketing approval for FIRDAPSE Tablets 10 mg , for the treatment of Lambert Eaton myasthenic syndrome ("LEMS") in Japan, based on preliminary favorable analysis results of interim data after six months into the safety phase of the registration study.
    • 15 Mar 2023 According to a Catalyst Pharmaceuticals media release, the company anticipate completion of study in late 2023, and if the study is successful, the company anticipates the filing of an application to market the product in Japan in the second quarter of 2024.
    • 06 Dec 2021 Status changed from planning to recruiting, according to a Catalyst Pharmaceuticals media release.

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