Product Spotlight - Ampyra

Ampyra (dalfampridine) is a potassium channel blocker taken orally as a treatment to improve walking in patients with multiple sclerosis (MS). Ampyra, previously referred to as Fampridine-SR, is provided in an extended-release tablet formulation of dalfampridine, which was previously called fampridine. The name was changed to dalfampridine to avoid confusion with other FDA-approved products.

The efficacy of dalfampridine for this indication was demonstrated by an increase in walking speed. The product was granted orphan drug status, providing 7 years of market exclusivity.

Dalfampridine can be used alone or with existing MS therapies, including immunomodulator drugs. The dose regimen is a 10-mg tablet twice daily, approximately 12 hours apart.

The safety and efficacy of dalfampridine was established in two phase 3 trials that used a responder analysis to determine the effect of treatment on walking speed.



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