Firdapse Approval History
Reviewed by J.Stewart BPharm Last updated on Nov 30, 2018.
FDA Approved: Yes (First approved November 28, 2018)
Brand name: Firdapse
Generic name: amifampridine phosphate
Dosage form: Tablets
Company: Catalyst Pharmaceuticals, Inc.
Treatment for: Lambert Eaton Myasthenic Syndrome
Firdapse (amifampridine phosphate) is a nonspecific, voltage-dependent, potassium (K+) channel blocker for the treatment of Lambert Eaton myasthenic syndrome (LEMS) in adults.
- LEMS is a rare autoimmune disease that affects approximately 1 in 100,000 people in the United States. The most common symptoms are proximal muscle weakness and fatigue, which can be life threatening when the weakness involves respiratory muscles.
- The efficacy of Firdapse was established in two Phase 3 clinical trials where patients treated with Firdapse experienced improvements in muscle function, and reduced weakness and fatigability compared to patients receiving placebo.
- Firdapse is taken orally in divided doses (3 to 4 times daily).
- The most common (> 10%) adverse reactions are paresthesia, upper respiratory tract infection, abdominal pain, nausea, diarrhea, headache, elevated liver enzymes, back pain, hypertension, and muscle spasms.
Development History and FDA Approval Process for Firdapse
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