Fampyra is a medicine used to improve walking in adults (18 years and over) with Multiple Sclerosis (MS) related walking disability. In multiple sclerosis, inflammation destroys the protective sheath around the nerves leading to muscle weakness, muscle stiffness and difficulty walking.
Fampyra contains the active substance fampridine which belongs to a group of medicines called potassium channel blockers. They work by stopping potassium leaving the nerve cells which have been damaged by MS. This medicine is thought to work by letting signals pass down the nerve more normally, which allows you to walk better.
What is Fampyra?
- Fampyra is a slow-release oral tablet indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability.
How does Fampyra work?
- The tablet contains a sustained release formula of 4-Aminopyridine, which blocks tiny pores, or potassium channels, on the surface of nerve fibres. This blocking may improve the conduction of nerve signals in nerve fibres whose insulating myelin coating has been damaged by MS.
- Taking Fampyra does not change the underlying course of the disease or limit the damage caused by the disease. It addresses the unmet medical need of walking improvement in MS with demonstrated efficacy in adults with MS.
How is Fampyra administered?
- Fampyra is administered orally by tablet twice a day, 12 hours apart. It should be taken without food.
Who should take Fampyra?
- In clinical trials, a proportion of people with all types of MS were found to benefit in terms of walking speed.
What are the side effects of taking Fampyra?
- It was generally well tolerated in the clinical studies within the recommended dose of 10mg twice daily; most side effects were mild and resolved within hours or a few days.
- The side effects seen were mostly neurological (relating to the brain or nerves) and include seizures (fits), insomnia (difficulty sleeping), anxiety, problems with balance, dizziness, paraesthesia (unusual sensations like pins and needles), tremor, headache and asthenia (weakness). The most common side effect reported in clinical studies, affecting around 12% of the patients, is urinary tract infection.
- At higher doses, for example, 20 or 30mg twice daily, the risk of more serious side effects, including seizures, increases. For this reason it is important not to exceed the recommended daily dose.
Who should not take Fampyra?
- Fampyra should not be taken by people who may be hypersensitive (allergic) to fampridine or any of the other ingredients. It should not be used with other medicines that contain fampridine or medicines known as ‘inhibitors of organic cation transporter 2’ such as Cimetidine. It should not be administered to patients who have seizures or have ever had seizures or in patients with kidney problems.
- No data is available for Fampyra’s safety or efficacy with respect to pregnant women, women breastfeeding and paediatric patients.
Why has Famprya been approved for use?
- The Committee on Medical Products for Human Use (CHMP), responsible for preparing the EMEA’s opinions on all questions concerning medicines for human use, considered that Fampyra was likely to benefit approximately one third of patients with MS who have a walking disability, and that patients benefiting from the treatment can be identified at an early stage allowing treatment to be stopped in other patients.
- The Committee noted that no other medicine was currently approved to treat the symptoms of MS and that the serious side effects with Fampyra were rare. The CHMP therefore concluded that the benefits of Fampyra outweigh its risks for patients with a walking disability and recommended that it be given ‘conditional’ marketing authorisation.
What information is still awaited for Fampyra?
- In order to meet the obligations of conditional approval (which is renewable annually), a double-blinded, placebo-controlled, study on the long term efficacy and safety of Fampyra is being undertaken.
- The study will look at the effects of Fampyra on other aspects of walking ability besides walking speed, investigating a broader primary endpoint clinically meaningful in terms of walking ability. It will further evaluate the early identification of responders in order to guide further treatment. Every year, the European Medicines Agency will review any new information that may become available and update its position as necessary.
Is Fampyra be available in Ireland?
- Fampyra is now available in Ireland and is reimbursed by the HSE on a ‘responder’ basis. This means the HSE will only pay for the drug for those for whom it is proven to have an effect.
- Our additional information sheet ‘Fampyra Frequently Asked Questions’ provides further information on the prescribing and reimbursement of Fampyra.
- MS Ireland provides information to the MS Community on an array of topics associated with MS. This information is for reference purposes only and medical advice should always be sought before any treatment or intervention is tried.
- http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medi cines/002097/human_med_001432.jsp&mid=WC0b01ac058001d124
- EMEA Fampyra Summary of Product Characteristics
- http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Product_Information/human/002097/WC500109956.pdf
- EMEA - Committee for Medicinal Products for Human Use (CHMP). Positive opinion on the marketing authorisation for Fampyra (fampridine). Date: May 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinio n_-_Initial_authorisation/human/002097/WC500106531.pdf
- Medicines.ie Fampyra Summary of Product Characteristics
- http://www.medicines.ie/medicine/15152/SPC/Fampyra+10+mg+prolonged- release+tablets/#AUTHDATE
- Multiple Sclerosis Resource Centre – Fampyra News
- MS Trust Fampyra Fact Sheet
- National Council for PharmacoEconomics Fampyra
- NHS Report on Fampridine
- http://www.netag.nhs.uk/files/appraisal-reports/Fampridine%20in%20MS%20- %20NETAG%20appraisal%20report%20-Mar2012.pdf