Acorda reports data for Ampyra postmarketing commitment

Acorda Therapeutics Inc. (NASDAQ:ACOR) reported data from a Phase III postmarketing commitment study comparing the approved twice-daily 10 mg dose of Ampyra dalfampridine to an unapproved 5 mg dose of the multiple sclerosis drug. Both doses missed the primary endpoint of improving walking speed on the Timed 25-Foot Walk (T25FW) test from baseline to week four vs. placebo. However, a post hoc analysis of the average change in T25FW from baseline showed that high-dose Ampyra significantly improved average walking speed from baseline by 0.443 ft/sec vs. 0.303 ft/sec for placebo (p=0.014), while the low dose did not. Additionally, a responder analysis showed that 10 mg Ampyra significantly improved the proportion of patients who experienced at least a 20% average improvement in walking speed from baseline; 5 mg Ampyra did not significantly improve the endpoint. ...