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#27 Joyce Anne T.

Miranda
#28 Samantha Louise S. Mondoñedo
2FPH

A Critique Paper With Reference To The Article:
Single-Dose Pharmacokinetics of Sustained-Release Fampridine(Fampridine-SR)
in Healthy Volunteers and Adults with Renal Impairment

Citation

Smith, W., Swan, S., Marbury, T., & Henney, H. (2010). Single-Dose
Pharmacokinetics of Sustained-Release Fampridine (Fampridine-SR) in Healthy
Volunteers and Adults With Renal Impairment. Journal of Clinical Pharmacology,
50(2), 151-159.

Topic

The study describes the pharmacokinetics of Fampridine-SR and its metabolites in
healthy volunteers and in individuals with various degrees of renal impairment. The
study was conducted in 2 phases, Phase 1 was to establish the safety and
pharmacokinetic profile of fampridine–SR in subjects with moderate renal
impairment and to confirm that the dose and sampling regimen were appropriate for
phase 2, which enrolled healthy individuals and subjects with mild, moderate, or
severe renal impairment. Plasma and urine samples were analyzed for fampridine and
its metabolites using validated liquid chromatography/mass spectrometry procedures.

Fampridine is a potassium channel blocker that has been shown in animal models
to restore neuronal conduction in focally demyelinated axons. Fampridine-SR; in the
study, fampridine-SR was well tolerated by all patients, including those with various
stages of renal impairment. Pharmacokinetics; the results reported show that the
pharmacokinetics of fampridine-SR 10mg in healthy volunteers are consistent with
what has previously been reported in patients with spinal cord injury and has been
founs in patients with MS (as determined in steady-state and escalating-dose studies;
data on file, Acorda Therapeutics). In patients with renal impairment, mean
fampridine plasma concentrations were consistently higher while excretion was
lower.


Theory/Research

The research method of the study that was used was Quasi-experimental for it
shows the comparison of the pharmacokinetics of Fampridine-SR in healthy
volunteers and in individuals with various renal impairment. The study was a
multicenter, parallel-group, open-label, single-dose study of fampridine-SR 10mg
tablets (Elan Corporationplc, Dublin, Ireland) conducted in healthy and renally
impaired subjects. A total of 20 subjects were enrolled in the study and assigned 1 to
#27 Joyce Anne T. Miranda
#28 Samantha Louise S. Mondoñedo
2FPH

4 groups based on their degree of renal impairment. Pharmacokinetics and Statistical
Analyses; Plasma pharmacokinetic parameters were calculated from the individual
plasma concentrations of fampridine and its metabolites using noncompartmental
methods.

Abstract

Fampridine-SR is a sustained-release formulation of fampridine (4-
aminopyridine), a potassium channel blocker demonstrated to improve walking
ability in patients with multiple sclerosis. This study evaluated the pharmacokinetics
of fampridine and its metabolites after administration of fampridine-SR 10mg in
healthy volunteers and in subjects with mild, moderate, or severe renal impairment.
(Smith et al)

Conclusion

After the tabulation of the results from the given study, the data implies that
excessive accumulation may occur with repeated dosing in patients with severe renal
impairment, in which exclude the use of fampridine-SR 10-mg tablets. In this study
none of the 20 subjects dropped out of the study because of AEs; no deaths, serious
AEs, or significant AEs were reported. (Smith et al) In view of the fact that
fampridine has a narrow therapeutic scope, it will also be sensible to monitor patients
that are being studied with mild renal impairment for potential AEs.

Reflection

Based on this study, the proponents have come to an understanding that this
research has been an important help to patients with multiple sclerosis and as well as
people with renal impairment. This study made them apprehend that methods that
were used in this research are very tedious. It requires a lot of time and effort for
fampridine undergoes a lot of process before it has been authorized to treat adult
patients that are renally impaired. Some procedures used in yielding fampridine are
relatively familiar to the proponents. Thus, making them appreciate all the techniques
that are being acquired to them and make use of them in their future researches. It
also necessitates funds for the methods and the active ingredients utilized for
fampridine are reasonably costly.