Acorda Therapeutics Inc. (ACOR) announced that data from a long-term open-label extension study from the first Phase 3 Fampridine-SR trial, known as MS-F203, showed that 24.9% of extension study participants with multiple sclerosis or MS met the criteria as Extension Timed Walk Responders or ETWRs)after one year of treatment and demonstrated improved walking speed over a two year period. In addition, the safety profile of Fampridine-SR observed over two years in this study was consistent with previous placebo-controlled trials.
In the 14-week placebo-controlled portion of the MS-F203 study, 34.8% of subjects were defined as Timed Walk Responders in the Fampridine-SR group compared to 8.3% of subjects in the Placebo group.
A total of 187 of the 269 or 69.7% subjects who enrolled in the extension trial were still enrolled at the time of the analysis, with an average exposure of 2.1 years.
The company noted that there were 82 discontinuations or 30.5%, 29 of which were due to adverse events or 10.8%. The most commonly reported adverse events in the study were: urinary tract infection or 34.6%, MS relapse (31.2%), fall (29.7%), arthralgia (16.4%) and asthenia (16.0%). Over two years of treatment, 63 study participants or 23.4% experienced at least one serious adverse event. The most frequent serious adverse events were MS relapse (4.1%), cellulitis (1.9%) and convulsion (1.1%).
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