Sustained-Release Fampridine for Symptomatic Treatment of Multiple Sclerosis

@article{Korenke2008SustainedReleaseFF,
  title={Sustained-Release Fampridine for Symptomatic Treatment of Multiple Sclerosis},
  author={Anne R Korenke and Michael P. Rivey and Douglas R Allington},
  journal={Annals of Pharmacotherapy},
  year={2008},
  volume={42},
  pages={1458 - 1465}
}
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… 
[4-Aminopyridine (Fampridine). A new attempt for the symptomatic treatment of multiple sclerosis].
TLDR
A recently conducted randomized, placebo-controlled, multicenter phase 3 clinical trial in MS patients was able to show that an oral sustained-release formulation of 4-aminopyridine (Fampridine-SR) represents a suitable agent for treatment of walking disability in patients.
Impact of extended-release dalfampridine on walking ability in patients with multiple sclerosis
  • K. Hayes
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  • 2011
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The mechanism of action and chemistry of dalfampridine ER, its pharmacokinetics, tolerability, and side effects, and the outcomes of multicenter trials showing its efficacy in improving walking speed are described.
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TLDR
Extended-release 4-aminopyridine became the first drug specifically licensed to improve walking in patients with multiple sclerosis in 2010 and various reports indicate clinical efficacy beyond multiple sclerosis, which may broaden its use in clinical practice.
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TLDR
Oral dalfampridine ER 10 mg twice daily was generally well tolerated in patients with MS, according to the results of the three randomized, double-blind, placebo-controlled trials.
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TLDR
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TLDR
Dalfampridine serves as proof-of-concept that targeting axonal transmission can improve disability in multiple sclerosis.
Dalfampridine: Review on its recent development for symptomatic improvement in patients with multiple sclerosis
Abstract Multiple sclerosis (MS) is a neurodegenerative disease of the central nervous system (CNS), causes irreversible disability in young adults but the cause and cure were unknown and it involves
4-Aminopyridine Toxicity: a Case Report and Review of the Literature
TLDR
The commonalities associated with 4-AP toxicity conforms to what is known about its mechanism of action combining cholinergic features including diaphoresis, altered mental status, and seizures with dopamine-related movement abnormalities including tremor, choreoathetosis, and dystonia.
Dalfampridine (Ampyra) for multiple sclerosis.
TLDR
The FDA approved orphan drug status for dalfampridine extendedrelease tablets, which will be marketed under the brand name Ampyra, which is indicated to improve walking in patients with MS, a novel agent that targets MS symptoms.
Dalfampridine: Review of its Efficacy in Improving Gait in Patients with Multiple Sclerosis
TLDR
Dalfampridine, which acts at the central and peripheral nervous systems, enhances conduction in demyelinated axons and improves walking ability of MS patients and is recently approved by FDA for symptomatic treatment of MS.
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References

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The use of 4-aminopyridine (fampridine) in demyelinating disorders.
TLDR
The randomized clinical trials that have been completed to date indicate that K+ channel blockade may prove to be a useful strategy for ameliorating central conduction deficits due to demyelination, but the clinical trials have not provided sufficiently robust or definitive evidence of efficacy to gain regulatory approval for the symptomatic management of patients with either multiple sclerosis or spinal cord injury.
Fampridine-SR in multiple sclerosis: a randomized, double-blind, placebo-controlled, dose-ranging study
TLDR
Improvements were seen in lower extremity muscle strength and walking speed in the Fampridine-SR group compared to placebo and there were no significant differences in other MSFC measure or fatigue scores.
Dose comparison trial of sustained-release fampridine in multiple sclerosis
TLDR
This phase 2 study suggests that a subgroup of patients, when treated with fampridine, experiences a clinically relevant improvement in walking ability, which is sustained for at least 14 weeks.
Quantitative assessment of sustained‐release 4‐aminopyridine for symptomatic treatment of multiple sclerosis
TLDR
The quantitative outcomes used in this study permit more sensitive evaluation of the therapeutic effect and promise to be useful in future trials of symptomatic treatments for MS.
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TLDR
It is suggested that AP serum levels should be monitored and peak levels above 100 ng/ml should be avoided, and concentration-control methodology may be useful in testing putative treatments for other neurologic diseases.
Fampridine-SR for multiple sclerosis and spinal cord injury
  • K. Hayes
  • Medicine
    Expert review of neurotherapeutics
  • 2007
Fampridine-SR is a sustained-release tablet form of the K+ channel-blocking compound 4-aminopyridine that has been shown to restore conduction in focally demyelinated axons, to enhance synaptic
Randomised double-blind placebo-controlled study of interferon β-1a in relapsing/remitting multiple sclerosis
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Subcutaneous interferon β-1a is an effective treatment for relapsing/remitting MS in terms of relapse rate, defined disability, and all MRI outcome measures in a dose-related manner, and it is well tolerated.
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TLDR
The MRI results demonstrate that IFNB has made a significant impact on the natural history of MS in these patients and support the clinical results in showing a significant reduction in disease activity as measured by numbers of active scans and appearance of new lesions.
Pharmacokinetics of an Immediate‐Release Oral Formulation of Fampridine (4‐Aminopyridine) in Normal Subjects and Patients with Spinal Cord Injury
TLDR
The Fampridine compound was well tolerated, with only mild and transient side effects of light‐headedness, dysesthesias, and dizziness, and there were no obvious differences in the plasma concentration profiles between control subjects and SCI patients.
Intramuscular interferon beta‐1a for disease progression in relapsing multiple sclerosis
TLDR
Interferon beta‐ la had a significant beneficial impact in relapsing multiple sclerosis patients by reducing the accumulation of permanent physical disability, exacerbation frequency, and disease activity measured by gadolinium‐enhanced lesions on brain magnetic resonance images.
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