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A Phase 3, Double-Blind, Placebo-controlled, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Amifampridine Phosphate in Patients With Lambert-Eaton Myasthenic Syndrome

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Trial Profile

A Phase 3, Double-Blind, Placebo-controlled, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Amifampridine Phosphate in Patients With Lambert-Eaton Myasthenic Syndrome

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jun 2024

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At a glance

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

    • Most Recent Events

    • 30 May 2024 According to a Catalyst Pharmaceuticals media release, company announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) increasing the indicated maximum daily dose of FIRDAPSE (amifampridine) for adults and pediatric patients weighing more than 45 kg from 80 mg to 100 mg for the treatment of Lambert-Eaton myasthenic syndrome.
    • 13 Oct 2023 According to a Catalyst Pharmaceuticals media release,Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS.
    • 13 Oct 2023 According to a Catalyst Pharmaceuticals media release, the U.S.FDA has accepted for review the Company's supplemental New Drug Application ("sNDA") to increase the indicated maximum daily dosage of FIRDAPSE (amifampridine) Tablets 10 mg from 80mg to 100mg for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS").The Prescription Drug User Fee Act ("PDUFA") action date is June 4, 2024.

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