Drug Evaluation

Mayo Graduate School of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA

† Author for correspondence

Email the corresponding author at rodriguez.moses@mayo.edu

Published Online:21 Sep 2010https://doi.org/10.2217/fnl.10.52

Abstract

Dalfampridine is a potassium-channel blocker that is approved by the US FDA as 10 mg extended-release tablets to improve walking in patients with multiple sclerosis. Approval is currently pending in Europe. This is the first pharmacological symptomatic treatment approved for multiple sclerosis patients of any type with walking difficulties. Relative to an immediate-release formulation, the extended-release formulation of dalfampridine lowers peak serum concentrations that contribute to toxicity while maintaining a comparable amount of total drug exposure. Several studies show the efficacy and tolerability of dalfampridine. The pivotal published clinical trial demonstrated a treatment–responder rate of 35% compared with an 8% placebo–responder rate (p < 0.0001). The subjects who responded to treatment had an average improvement in their 25-foot walking test time of 25.2% (95% CI: 21.5–28.8) compared with an average improvement of 4.7% (95% CI: 1.0–8.4) in subjects who responded to placebo. Seizures are the most serious adverse effect of dalfampridine with a probable dose-dependent likelihood of occurrence.

Keywords:

Papers of special note have been highlighted as: ▪ of interest ▪▪ of considerable interest

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Published online 21 September 2010

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Financial & competing interests disclosure

Acorda has licensed technology on the use of monoclonal antibodies for the treatment of multiple sclerosis from the Mayo Clinic. This work has no relationship to the work presented in this manuscript on dalfampridine. There is a future potential financial conflict of interest if these antibodies come to market. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

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Dalfampridine for the treatment of ambulatory impairment in multiple sclerosis

Abstract

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