NDAORALTABLETPriority Review
Approved
Nov 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
7/8 — Comprehensive
Priority Review
FIRDAPSE (amifampridine phosphate) by Catalyst Pharmaceuticals is elucidated. First approved in 2018.
Drug data last refreshed 4h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FIRDAPSE (amifampridine phosphate) is an oral small-molecule potassium channel blocker approved in November 2018 for Lambert-Eaton myasthenic syndrome (LEMS). It works by blocking potassium channels to enhance acetylcholine release at the neuromuscular junction, improving muscle strength and function in patients with this rare autoimmune disorder.
$0.146BPart D
Peak10.4 years to LOEProduct is in peak commercial phase with $146M in Medicare spending and no direct competitors, positioning the brand team for stable market defense and market expansion opportunities.
Mechanism of Action
elucidated. Amifampridine is a broad-spectrum potassium channel blocker.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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
Worked on FIRDAPSE at Catalyst Pharmaceuticals? Share your interview experience or compensation data (+7 days Pro)
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.