Fampridine-SR ("4-aminopyridine", "4-AP") is an investigational oral, sustained-release tablet formulation of 4-aminopyridine. In laboratory studies fampridine has improved impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Clinical History of Fampridine-SR in Multiple Sclerosis (MS) Results from the latest Phase 2 clinical trial showed a positive trend in improvement in walking speed and a statistically significant improvement in a measurement of leg muscle strength. The adverse events, including serious adverse events, seen in these studies were insomnia, paresthesias (numbness/tingling), dizziness and nausea, the majority of which were rated as mild to moderate. Seizure was reported in a small number of patients at higher doses than we are currently evaluating. As Fampridine-SR is an investigational drug, safety and efficacy have not been fully determined. In June 2005, Acorda initiated a Phase 3 clinical trial designed to evaluate the effects of Fampridine-SR on walking ability in people with MS. The study is a double-blind, placebo-controlled trial that will enroll a total of 240 people at approximately 30 of the leading MS clinical centers in the United States and Canada. http://www.acorda.com/pipeline_fampridine_ms1.asp To learn about Fampridine-SR�s mechanism of action click here. Bibliography of Fampridine-SR Publications |
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