ACORDA ANNOUNCES POSITIVE RESULTS FROM MS WALKING STUDY

Acorda Therapeutics has announced positive results from its Phase III trial of Fampridine-SR on multiple sclerosis (MS) patients' ability to walk. Statistical significance was achieved on all three efficacy 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, the study's primary outcome, compared with people taking placebo (34.8 percent versus 8.3 percent) as measured by the Timed 25-Foot Walk. In addition, the effect was maintained in this study throughout the 14-week treatment period and there was a statistically significant improvement in the 12-Item MS Walking Scale for walking responders versus non-responders.

The average increase in walking speed over the treatment period compared with baseline was 25.2 percent for the drug group versus 4.7 percent for the placebo group. 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 in both the Fampridine-SR Timed Walk responders and the Fampridine-SR Timed Walk non-responders compared with placebo.

The double-blind, placebo-controlled trial was designed to evaluate the safety and efficacy of Fampridine-SR in improving walking ability in people with MS. The trial, which enrolled 301 individuals at 33 MS centers in the United States and Canada, recruited patients between 18 and 70 years old with a definite diagnosis of MS and some degree of walking disability. The study was open to people with all types of MS, including primary-progressive, secondary-progressive, relapsing-remitting and progressive-relapsing. Participants were permitted to remain on a stable regimen of their current medications, including interferons. Secondary endpoints for the trial included measurements of leg strength.