6:00AM Acorda Therapeutics announces top line results of post-marketing commitment study exploring 5 mg Dose of Dalfampridine-ER; says not statistically significant compared to placebo (ACOR) 21.72 : The primary outcome was the change in walking speed on the Timed 25-Foot Walk test at Visit 3, measured at the time of peak plasma drug concentration, versus baseline. Improvements in the primary outcome for the 5 mg dose and the 10 mg dose at Visit 3 were not statistically significant compared to placebo. The AMPYRA Extended Release Tablets, 10 mg registration studies used a consistent response analysis to allow for the variability in MS-related symptoms, including walking ability. The design of the current study required a single endpoint analysis that had not been used previously in the AMPYRA development program. In a post-hoc analysis, T25FW data were analyzed with methods similar to those used in the pivotal studies, combining all measures prior to treatment as the baseline and all measures on treatment as the on-drug value. The average change from baseline in walking speed was significantly greater for the 10 mg group compared to placebo but not for the 5 mg group. No new safety signals were observed in this study. No seizures were reported. Two participants experienced serious adverse events in each of the 5 mg and the 10 mg treatment groups, including loss of consciousness in one patient in the 10 mg group who had discontinued dalfampridine-ER four days prior to the event.
