NDAORALTABLETPriority Review
Approved
Nov 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
8/8 — Comprehensive
Priority Review
FIRDAPSE (amifampridine phosphate) by Catalyst Pharmaceuticals is elucidated. Approved for lambert-eaton myasthenic syndrome. First approved in 2018.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FIRDAPSE (amifampridine phosphate) is an oral potassium channel blocker approved by the FDA in November 2018 for treating Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder affecting neuromuscular transmission, characterized by muscle weakness and autonomic dysfunction. Amifampridine works by blocking potassium channels, which enhances acetylcholine release at the neuromuscular junction and restores muscle function. FIRDAPSE represents the first FDA-approved treatment specifically indicated for LEMS, filling a significant unmet medical need in this ultra-rare disease.
$0.1BPart D
10.8 years to LOEMechanism of Action
elucidated. Amifampridine is a broad-spectrum potassium channel blocker.
Indications (1)
Clinical Trials (8)
Long Term Safety of Amifampridine Phosphate in Spinal Muscular Atrophy 3
Started Mar 2019
13 enrolled
Spinal Muscular Atrophy Type 3
Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients
Started Jan 2019
13 enrolled
Muscular Atrophy, Spinal
Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)
Started Jun 2018
63 enrolled
Myasthenia Gravis, MuSKAChR Myasthenia Gravis
Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG
Started Apr 2018
93 enrolled
Myasthenia Gravis, Generalized
Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS)
Started Nov 2016
26 enrolled
Lambert-Eaton Myasthenic Syndrome
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.