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NEW DRUG DEVELOPMENTS

Sustained-Release Fampridine for Symptomatic Treatment of Multiple Sclerosis

at time of writing, Pharmacy Practice Resident, Skaggs School of Pharmacy, The University of Montana; Community Medical Center, Missoula, MT; now, Assistant Professor, College of Pharmacy, Nursing, and Allied Health, North Dakota State University, Fargo, ND

Michael P Rivey, MS BCPS

Professor of Pharmacy Practice, Skaggs School of Pharmacy, The University of Montana; Clinical Pharmacy Consultant, Community Medical Center

Douglas R Allington, PharmD BCPS

Associate Professor of Pharmacy Practice, Skaggs School of Pharmacy, The University of Montana; Clinical Pharmacy Consultant, Community Medical Center

Reprints: Mr. Rivey, University of Montana Skaggs School of Pharmacy, 32 Campus Dr. #1522, Missoula, MT 59812, fax 406/243-4353, michael.rivey{at}umontana.edu

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical trials, and adverse effects of sustained-release (SR) fampridine in patients with multiple sclerosis (MS).

DATA SOURCES: An English-language human data search was done using PubMed/MEDLINE (1966–August 2008) to retrieve relevant material using the search terms fampridine-SR, 4-aminopyridine, and multiple sclerosis. References of selected articles and information from the drug developer were used to further identify pertinent trials.

STUDY SELECTION AND DATA EXTRACTION: Article selection was based primarily on studies that evaluated the pharmacokinetics, safety, and efficacy of fampridine-SR in patients with MS. Relevant meeting abstracts were also included as part of the analysis.

DATA SYNTHESIS: Fampridine-SR is a sustained-release, orally administered potassium-channel blocker acting in the central nervous system to enhance conduction in demyelinated axons. Several small trials have evaluated the safety and efficacy of fampridine-SR in patients with MS to improve their walking ability. Data from a recent large Phase 3 trial indicated that walking speed improved in 42.9% of patients with MS who were treated with fampridine-SR compared with 9.3% of those who received placebo (p < 0.001). Treatment-related adverse events associated with the use of fampridine-SR include dizziness, insomnia, nausea, and paresthesia. More severe adverse events, such as seizure, have occurred in patients receiving doses higher than those currently recommended.

CONCLUSIONS: Positive results from 2 Phase 3 clinical trials have put fampridine-SR on the path toward approval as a medication for improving walking speed and lower extremity strength in patients with MS.

Key Words: 4-aminopyridine, fampridine-SR, multiple sclerosis

Published Online, September 9, 2008. www.theannals.com, DOI 10.1345/aph.1L028

THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE UNIVERSAL PROGRAM NUMBER: 407-000-08-020-H01-P