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news.Acorda Therapeutics, a biotechnology company, has reported negative top line results from post-marketing commitment study exploring 5mg dose of Dalfampridine-ER in multiple sclerosis (MS) patients.
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The primary outcome of the study which randomized 430 participants across three treatment arms placebo, 5mg or the currently marketed dose of 10mg of dalfampridine-ER, twice daily, was change in walking speed (feet/second) on the Timed 25-Foot Walk test at Visit 3, measured at the time of peak plasma drug concentration, versus baseline.
Acorda chief medical officer Enrique Carrazana said the current study, together with the AMPYRA registration studies, continue to show that 10mg twice daily is the appropriate, safe and effective dose.
"The 5mg twice daily dose of dalfampridine-ER failed to show efficacy over placebo on the primary or secondary measures," Carrazana added.
According to the study, improvements in the primary outcome for the 5mg dose (0.423 ft/sec, p=0.457) and the 10mg dose (0.478 ft/sec, p=0.107) at Visit 3 were not statistically significant compared to placebo (0.363 ft/sec).
A planned secondary outcome measure of improvement in walking, the six-Minute Walk Test, was applied at Visit 2 in a subset of the study participants (approximately 50 randomized per treatment arm). The 10mg dose, but not the 5mg dose, showed a significant improvement compared to placebo, the study reported.
Changes in perceived effect of MS on walking-related activities showed improvements for the 10mg and 5mg groups that were not significant compared to placebo.
The FDA has approved Ampyra (dalfampridine) Extended Release Tablets 10mg as a treatment to improve walking ability in people with MS.