Background: Fampridine-SR is under submission as the first drug to be FDA approved with an indication specifically for multiple sclerosis symptoms. Compounded forms of the active agent of Fampridine-SR (4-aminopyridine) have been used in clinical practice for many years. Clinical trials have now been completed that demonstrate a robust capacity of the drug to meet stringent statistical and clinically meaningful end points.
Objective: To review the present understanding of multiple sclerosis, the proposed mechanism of action of Fampridine-SR in patients, the published data regarding its efficacy and safety in human clinical trials, and to discuss its potential clinical uses in MS.
Results/conclusion: Fampridine-SR 10 mg twice a day has been shown to be safe and effective in improving the ambulation of patients with walking disability due to MS. It will probably find clinical application beyond this specific indication in a significant proportion of patients.
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