RESEARCH PROFILES

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Fampridine Update:
SR Enters Phase 3 Clinical Trials in MS

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By Acorda Therapeutics

In May 2005, Acorda Therapeutics announced an agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment for a Phase 3 clinical trial of Fampridine-SR. This marked a pivotal moment in the history of the drug.

On May 4, 2005, Acorda Therapeutics announced that it had reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment for a pivotal, Phase 3 clinical trial of Fampridine-SR in multiple sclerosis (MS). A Special Protocol Assessment (SPA) is a process in which the FDA provides evaluation and guidance on clinical trial protocols for Phase 3 studies.

Results from the Phase 2 MS clinical trial showed a positive trend for improvement in average walking speed and a statistically significant improvement in LEMMT (which is a standardized manual assessment of leg strength).

Fampridine is a selective neuronal potassium channel blocker and has been shown to restore nerve conduction by blocking the exposed potassium channels in damaged nerve fibres that have lost their insulating sheath of myelin. By closing the channels, fampridine allows such nerve fibres to transmit impulses again. Fampridine-SR (also known as 4-AP) is an oral, sustained-release formulation of Fampridine.