Statistical significance was achieved on all three criteria defined in the Special Protocol Assessment by the FDA. A significantly greater proportion of people taking Fampridine-SR had a consistent improvement in walking speed, compared to people taking placebo. In addition, the effect was maintained in this study throughout the 14-week treatment period.
Increased response rate on the Timed 25-Foot Walk was seen across all four major types of MS. In addition, statistically significant increases in leg strength were seen.
“We are delighted with the results from this trial, which are consistent with Acorda's prior phase II study in people with MS. We will request a meeting with the FDA as soon as possible to discuss next steps for the Fampridine-SR program,” said Ron Cohen, president and CEO of Acorda.
“Many people with MS experience nerve damage that eventually impairs walking. Currently, no therapies are indicated to improve neurological function, such as loss of mobility, in MS,” said Andrew Goodman, director of the Multiple Sclerosis Center at the University of Rochester.
“Based on the results of this trial, Fampridine-SR could represent a new way to treat people with MS. In this study, a significantly higher proportion of subjects experienced a consistent improvement in walking speed with Fampridine-SR than with placebo, and this was accompanied by a reduction in the degree of disability that the subjects reported in their daily activities related to mobility.”