NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Jan 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
6/8 — Strong
Priority Review
AMPYRA (dalfampridine) by Merz Therapeutics is potassium channel antagonists [moa]. Approved for multiple sclerosis. First approved in 2010.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMPYRA (dalfampridine) is an oral extended-release tablet approved in January 2010 as a potassium channel antagonist for improving walking in adults with multiple sclerosis. It works by blocking potassium channels, which enhances neuronal conduction in demyelinated axons. AMPYRA is a symptomatic therapy uniquely positioned to improve mobility rather than disease-modifying activity, filling a distinct niche in the MS treatment portfolio.
$0.0BPart D
Mechanism of Action
Potassium Channel Antagonists
Pharmacologic Class:
Potassium Channel Blocker
Indications (1)
Clinical Trials (3)
FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra
Started Jun 2012
108 enrolled
Multiple Sclerosis
An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice
Started Apr 2012
4,734 enrolled
Multiple Sclerosis
Dalfampridine for Imbalance in Multiple Sclerosis
Started Sep 2011
24 enrolled
Multiple SclerosisFatigue
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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.