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Fampridine (Fampyra)

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  1. How is fampridine given?
  2. Side effects and contraindications
  3. Being prescribed fampridine
  4. Licensing and availability
  5. How fampridine works
  6. Fampridine research

Other names: Ampyra (US), dalfampridine

Fampridine is a drug that has been shown to improve walking speed for some adults with multiple sclerosis.

It has been approved for use by NHS Wales and NHS Scotland for the improvement of walking in adults with MS who have an EDSS between 4 and 7.  It is not currently available on the NHS in England or Northern Ireland.

In 2018, the patent on fampridine expired, and a cheaper version of the drug, called dalfampridine, was developed and licensed in the US.

How is fampridine given?

Fampridine is taken orally as tablets. Most people are prescribed one tablet in the morning and one at night. Fampridine is formulated as a prolonged-release tablet which means that the drug is released slowly to give a more steady supply of fampridine in the body.

Side effects and contraindications

Urinary tract (bladder) infections are very common. Other common side effects include dizziness, headache, back pain, difficulty sleeping, feeling sick and stomach upsets. Dalfampridine may worsen trigeminal neuralgia.

Being prescribed fampridine

Fampridine is only available on prescription under the supervision of a doctor with knowledge of MS. The doctor usually provides an initial prescription for two to four weeks and then the treatment is assessed to see if it is working, usually by timing how long it takes to walk a short distance (eg. 25 feet).

Up to a third of people find that fampridine improves their mobility, so only this group would be prescribed fampridine in the longer term. The initial two to four week trial is currently funded by the manufacturer.

Licensing and availability

Fampridine was granted a conditional marketing authorisation by the European Medicines Agency (EMA) in July 2011. A conditional marketing authorisation is granted when a medicinal product is considered to fulfil an unmet medical need and should be made available despite the fact that further data are still required. The licence required the manufacturer, Biogen Idec, to carry out further research into the benefits and long-term safety of fampridine. This research was completed in 2016 and in May 2017 a full licence was granted.

There have been repeated attempts to get fampridine recommended for use within the NHS of different nations in the UK. This would mean it could be prescribed as a normal prescription medicine, with the standard costs for that nation.

In England, fampridine is currently not recommended for use within the NHS. The most recent ruling in the NICE Clinical Guideline for MS from 2014 was revised in 2018 with no change.

In Wales, fampridine was recommended for use within the NHS in December 2019. It must be supplied through a Wales Patient Access Scheme. This is an arrangement where a medicine can be offered on a exceptional basis through an agreement with the pharmaceutical company that supplies it. It is not clear how quickly Health Boards in Wales will make fampridine widely available on prescription. 

In Scotland, fampridine was recommended for use within the NHS in April 2020.

How fampridine works

Fampridine is a formulation of 4-aminopyridine, a potassium channel blocker. It works by stopping potassium leaving nerve cells which have been damaged by MS. This lets signals pass down the nerve more normally. Consequently, some people are able to walk better.

For reasons that are not understood, some people respond well to fampridine and experience improved mobility, but others do not.

Fampridine research

There have been a number of clinical trials of fampridine. For example, a phase III study involving 301 people with relapsing or progressive MS who were treated for 14 weeks, showed a greater proportion of people taking fampridine had a consistent improvement in walking speed compared to people taking placebo (35% v 8%). This improvement was maintained for the duration of the study.

A review of a wide range of clinical trials by NICE, completed as part of the development of the 2014 MS Clinical Guideline, concluded that fampridine had a positive effect on walking speed compared with placebo. However, there was little good evidence for an appreciable effect on EDSS, a commonly used measure of disability.

In 2019, the ENHANCE trial of fampridine reported a clinically meaningful improvement in walking ability (not just speed) in patients who had taken fampridine, compared to placebo. This study included 636 adults with MS who had an EDSS between 4 and 7.

Find out more

References

  • Goodman AD, et al. Dose comparison trial of sustained-release fampridine in multiple sclerosis. Neurology 2008;71(15):1134-1141. Summary
  • Goodman AD, et al. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet 2009;373(9665):732-738. Summary
  • Rabadi MH, et al. Sustained-release fampridine (4-aminopyridine) in multiple sclerosis: efficacy and impact on motor function. Drugs in R&D 2013;13(3):175-181. Summary
  • Biogen’s Fampyra granted Standard Marketing Authorization in European Union for improvement of walking in people with MS Biogen press release - 24 May 2017 Read online
  • Hobart J, Ziemssen T et al. Assessment of Clinically Meaningful Improvements in Self-Reported Walking Ability in Participants with Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III ENHANCE Trial of Prolonged-Release Fampridine CNS Drugs January 2019, 33:1:61-79 Read online
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