This site is intended for health professionals only
A new drug may offer the hope of improved mobility to people with multiple sclerosis (MS).
According to the US Food and Drug Administration (FDA), the Acorda Therapeutics’ phase III clinical trial of Fampridine-SR showed positive results.
A significantly greater proportion of people taking Fampridine-SR in the trial had a consistent improvement in walking speed compared to people taking placebo (42.9% vs 9.3%).
Ron Cohen, MD, President and CEO of Acorda Therapeutics, said: “We believe that, subject to FDA review, the results of our two phase III trials are adequate to support an New Drug Application. We expect to submit this application in the first quarter of 2009 and plan to request priority review.”
The study also showed a small improvement in leg strength for Fampridine-SR Timed Walk responders compared to placebo (p = 0.028).
Multiple sclerosis is a chronic, usually progressive disease in which the immune system attacks and degrades the function of nerve fibres in the brain and spinal cord.
“Difficulties with walking are among the most pervasive and debilitating problems faced by people with MS. Walking disability affects their ability to accomplish daily tasks and limits their independence,” said Andrew Goodman MD, Director of the Multiple Sclerosis Center at the University of Rochester in the US.
Copyright © PA Business 2008