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Firdapse (AMIFAMPRIDINE)
Firdapse (generic name: AMIFAMPRIDINE) is a Potassium Channel Blocker Small molecule drug developed by Catalyst Pharms. It is currently FDA-approved (first approved 2018) for Eaton-Lambert syndrome.
Firdapse works by blocking potassium channels in the nervous system, allowing more nerve impulses to be transmitted.
Firdapse (amifampridine) is a small molecule potassium channel blocker developed by Catalyst Pharms, targeting the voltage-gated potassium channel. It was FDA-approved in 2018 for the treatment of Eaton-Lambert syndrome. Firdapse is a patented medication with no generic manufacturers available. Key safety considerations include potential for seizures and cardiac arrhythmias. It is essential to monitor patients for these adverse effects.
At a glance
| Generic name | AMIFAMPRIDINE |
|---|---|
| Sponsor | Catalyst Pharms |
| Drug class | Potassium Channel Blocker |
| Target | Voltage-gated potassium channel |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2018 |
| Annual revenue | 400 |
Mechanism of action
The mechanism by which amifampridine exerts its therapeutic effect in LEMS patients has not been fully elucidated. Amifampridine is broad spectrum potassium channel blocker.
Approved indications
- Eaton-Lambert syndrome
Common side effects
- Paresthesia
- Upper respiratory tract infection
- Abdominal pain
- Nausea
- Diarrhea
- Headache
- Elevated liver enzymes
- Back pain
- Hypertension
- Muscle spasms
- Dizziness
- Asthenia
Key clinical trials
- Firdapse for Post-BOTOX Vocal Weakness (PHASE2)
- Pilot Study on the Usefulness of 3,4-diaminopyridine in the Treatment of Botulism (PHASE2,PHASE3)
- Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS),Congenital Myasthenic Syndrome
- Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA (PHASE1)
- Treatment Use of 3,4-Diaminopyridine
- Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis) (PHASE3)
- Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG (PHASE3)
- Long Term Safety of Amifampridine Phosphate in Spinal Muscular Atrophy 3 (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Firdapse CI brief — competitive landscape report
- Firdapse updates RSS · CI watch RSS
- Catalyst Pharms portfolio CI
Frequently asked questions about Firdapse
What is Firdapse?
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What is Firdapse used for?
Who makes Firdapse?
What is the generic name of Firdapse?
What drug class is Firdapse in?
When was Firdapse approved?
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What are the side effects of Firdapse?
What is Firdapse's annual revenue?
What does Firdapse target?
Related
- Drug class: All Potassium Channel Blocker drugs
- Target: All drugs targeting Voltage-gated potassium channel
- Manufacturer: Catalyst Pharms — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Eaton-Lambert syndrome
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing