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Pharmacokinetics of an Immediate-Release Oral Formulation of Fampridine (4-Aminopyridine) in Normal Subjects and Patients with Spinal Cord Injury

From the Department of Physical Medicine and Rehabilitation, the University of Western Ontario, and the Program of Rehabilitation and Geriatric Care, Lawson Health Research Institute, St. Joseph's Health Care London, London, Ontario, Canada (K. C. Hayes, J. T. C. Hsieh, D. L. Wolfe, P. J. Potter); Acorda Therapeutics, Inc., Hawthorne, New York (M. A. Katz, A. R. Blight); and Elan Corp., Monksland, Athlone, Ireland (J. G. Devane).

Plasma concentration profiles of the K⁺ channel-blocking compound Fampridine were obtained from (1) control subjects (n = 6) following oral administration of doses of 10, 15, 20, and 25 mg and (2) patients with spinal cord injury (SCI) (n = 11) following a single oral dose of 10 mg of an immediate-release formulation. Plasma concentrations were determined using a reversed-phase ion-pair high-performance liquid chromatography (HPLC) assay with ultraviolet light detection employing liquid extraction. The drug was rapidly absorbed with a t_max 1 hour for both groups; t_max was independent of dose. C_max and AUC_0- were linearly related to dose, and t_1/2 was 3 to 4 hours for both groups. There were no obvious differences in the (10-mg) plasma concentration profiles between control subjects and SCI patients. The drug was well tolerated, with only mild and transient side effects of light-headedness, dysesthesias, and dizziness.

Key Words: Spinal cord injury • Fampridine • 4-aminopyridine • pharmacokinetics

Address for reprints: Keith C. Hayes, PhD, Parkwood Hospital/St. Joseph's Health Care, 801 Commissioners Road East, London, Ontario, Canada, N6C 5J1.

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