Fampridine

What is Fampridine-SR?

Fampridine-SR is a sustained-release tablet formulation of the investigational drug Fampridine 1. It is not licensed in any country, including the UK.

Fampridine-SR is not a disease-modifying medication; it targets MS symptoms, primarily by improving walking ability and lower leg strength.2

Fampridine-SR is a potassium-channel blocker that has completed two successful phase 3 clinical trials demonstrating improved walking ability in people with Multiple Sclerosis. It has been found to improve impulse conduction in nerve fibers in which myelin; the insulating layer has been damaged. 2,3  

Who is currently developing Fampridine-SR?

Fampridine-SR was developed using Elan’s proprietary Oral Controlled Release MXDAS™ (MatriX Drug Absorption System) Technology and will be manufactured by Elan based on an existing supply agreement with Acorda.1

Biogen Idec and Acorda announced a collaborative agreement to develop and commercialise Fampridine-SR outside the United States. 1

Acorda will continue to develop and commercialise Fampridine-SR independently in the US. 2

When will Fampridine be available in the UK or elsewhere?

Fampridine-SR is not currently licensed in the UK.

Acorda announced that Fampridine-SR is to be submitted for a licence application (Marketing Authorisation Application) to the European Medicines Agency (EMEA) during 2010. The regulatory process may take about 2 years.

The Food and Drug Administration (FDA) is currently reviewing a licence application for Fampridine-SR in the US. 4

What clinical data is available on the use of Fampridine-SR in patients with MS?

The results of two phase 3 studies are now available, investigating the efficacy and safety of 10mg twice daily Fampridine-SR in 4 types of MS patients (relapsing-remitting, primary progressive, secondary progressive and progressive relapsing).2,3

The first of these trials, designed to evaluate the effect of Fampridine-SR on walking ability, was a double-blind, placebo-controlled trial including 301 patients between the ages of 18 and 70 years with all 4 major classifications of MS. Subjects from 33 centers in the US and Canada were randomised in a 3:1 ratio to undergo a 2-week placebo run-in period followed by 14 weeks of treatment with either Fampridine-SR 10 mg twice daily or placebo. Statistical significance was achieved in the primary outcome, with 34.8% of Fampridine-SR patients compared with 8.3% of placebo patients making gains in the Timed 25-Foot Walk test (p < 0.001). The benefit from Fampridine-SR remained consistent throughout the 14-week treatment period. 2,3

The second phase 3 trial included 240 patients between the ages of 18 and 70 years from 39 centers across the US and Canada. The primary endpoint of the trial was the Timed 25-Foot Walk test. Increase in leg strength was a prospectively identified secondary outcome. Patients were randomised to receive either 10 mg of Fampridine-SR twice daily or placebo for 8 weeks. 3

Results showed that 42.9% of Fampridine-SR–treated patients had consistent improvements in their walking speed as compared with 9.3% of those receiving placebo (p < 0.001). Additionally, patients from the Fampridine-SR group who were identified as responders to treatment had an average increase in walking speed over the 8 weeks of 24.7%, whereas those in the placebo group showed a 7.7% improvement. An increase in leg strength was observed in Fampridine-SR responders compared with subjects on placebo (p = 0.028). 3

Treatment-related adverse events associated with the use of Fampridine-SR include dizziness, insomnia, nausea, and paresthesia. More severe adverse events, such as seizure, have occurred in patients receiving doses higher than those currently recommended.2,3

o Fampridine Sustained-Release Tablets Beneficial as Long-Term Therapy for Patients With MS

o Download MS News Issue 86 two page news feature looks at a selection of the therapies being tested at present

o FDA Approves Fampridine SR, Now Called Ampyra,™ to Improve Walking for People with All Types of MS -- Wholesale Price Announced, New Webcast Available from MS Canada Society. Read more

As always, we recommend speaking to your neurologist about any changes to your treatment