A recent National Multiple Sclerosis Society news release reports that in a post-marketing study of Amprya, it was unable to meet its primary endpoint. The study’s results indicate that a low dose, half of the dose approved by the US Food and Drug Administration (FDA), did not improve walking speed in multiple sclerosis (MS). Researchers add that while the full dose approved by the FDA did not meet its endpoint either, it did improve walking speed and endurance based upon several secondary measures. 

The results suggest that a Timed 25-Foot Walk did not improve significantly in either dose group when compared to the placebo. Researchers reportedly analyzed the data using approaches similar to those used in previous studies, finding that while the 10-milligram dose of Amprya significantly improved walking speed when compared to the placebo group, the 5-milligram dose did not. Researchers add that participants in the 10-milligram group exhibited average improvement in walking speed of 20% from baseline when compared to the placebo group.

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Source: National Multiple Sclerosis Society