Acorda Therapeutics (NASDAQ:ACOR) reported this morning that a 5mg dose of Ampyra was not as effective as the approved dose, Ampyra 10mg. The FDA required the company to conduct the low dose study when it originally approved the drug, which is used to help multiple sclerosis (MS) patients walk better.
Neither dose met the primary endpoint in the FDA-mandated trial reported today. However, the company emphasized that when endpoints similar to those used for the approval of Ampyra were analyzed, the 10mg dose showed statistically significant improvements vs. placebo in average walking speed and the number of responders to treatment, while the 5mg did not. (more…)