Fampyra® is the commercial brand name of Fampridine Sustained-release Tablets, a sustained-release oral potassium channel blocker developed by Biogen. It blocks voltage-gated potassium channels on demyelinated nerve axons, enhances nerve conduction velocity in damaged central nervous system nerve fibers, improves motor nerve signal transmission, and alleviates walking dysfunction caused by multiple sclerosis. This medicine is for oral administration only.
Main Indications
Improvement of walking ability in adult patients with multiple sclerosis (including relapsing-remitting, secondary progressive, primary progressive multiple sclerosis) with walking impairment.
Clinical Research
Global multicenter Phase III pivotal clinical trials verified that fampridine sustained-release tablets produced significant, durable improvements in walking speed, walking distance and motor function for multiple sclerosis patients with ambulatory dysfunction;
Clinical trials enrolling Chinese multiple sclerosis patients validated consistent motor function improvement efficacy and stable safety profiles matching global trial results;
Long-term extension studies confirmed sustained clinical benefit of repeated oral administration without obvious efficacy attenuation, supporting long-term symptomatic maintenance treatment for multiple sclerosis-related walking disability.
Common Side Effects
Common adverse reactions include insomnia, dizziness, headache, nausea, urinary tract infection, fatigue, back pain, balance disorder, paraesthesia;
Serious rare adverse reactions include seizures, renal function impairment, hypersensitivity reactions; adverse reactions are mostly mild to moderate, and symptoms can be relieved by dose adjustment or drug withdrawal.
Approval Status in China
Fampyra® (Fampridine Sustained-release Tablets, 10mg per tablet, 56 tablets per box) was approved for marketing by the National Medical Products Administration (NMPA) in China in 2021, introduced commercially by Biogen for symptomatic treatment of multiple sclerosis ambulatory impairment.
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