Health Canada approves PrFAMPYRA™ (fampridine) for therapy to improve walking
Health Canada has approvedPrFAMPYRA™ (fampridine) sustained release tablets, indicated for the symptomatic improvement of walking in adults with multiple sclerosis (MS) with walking disability (EDSS 3.5-7). Fampridine blocks tiny pores, or potassium channels, on the surface of nerve fibres, which may improve the conduction of nerve signals in along nerve fibres whose insulating myelin coating has been damaged by MS. Fampyra is expected to be available in Canadian pharmacies mid April 2012.
The efficacy of PrFAMPYRA in improving walking in people with MS was evaluated in two separate phase III randomized, placebo-controlled, parallel group trials involving a total of 540 people. The first study, MS-F203, was a 21-week study (one week post screening, two-week, single-blind placebo run-in, 14-week double-blind treatment, and 4-week no treatment follow-up) in 301 people with multiple sclerosis at 33 centres in the U.S. and Canada. The second study, MS-F204, was a 14-week study (one week post-screening, two weeks of single-blind, placebo run-in, nine weeks of double-blind treatment, and two weeks of no-treatment follow-up) in 239 people with multiple sclerosis at 39 centres in the U.S. and Canada. Walking speed in participants on therapy in both study groups increased by 25% compared with placebo. There was also a statistically significant improvement in leg strength.
Common side effects of fampridine include urinary tract infection, difficulty sleeping, dizziness, headache, nausea, weakness, back pain, problems with balance, MS relapse, burning, tingling or itching of the skin, irritation of the nose and throat, constipation, indigestion, throat pain. The initial prescription should be for no more than 4 weeks, and assessment for improvement in walking should be carried out within that timeframe.
The next step following Health Canada approval is for Fampyra to be reviewed by the Common Drug Review (CDR) of the Canadian Agency on Drugs and Technologies in Health (CADTH). Provincial governments then make the final determination regarding reimbursement using their own processes. CDR is a
pan-Canadian process for reviewing clinical, cost-effectiveness and patient evidence for drugs. It provides formulary listing recommendations to Canada’s publicly funded drug plans (except Quebec). The MS Society will provide input to the CDR and the provincial processes.
The MS Society will continue to provide updates on the availability of Fampyra as information becomes available.