Ampyra Trial Failure Is Not All Bad News For Acorda
This article was originally published in Pharmaceutical Approvals Monthly
Lower dose of Acorda’s MS drug Ampyra fails to meet primary endpoint in new study, reassuring investors on the IP front. But the higher, approved dose also missed the mark, which raises questions about a negative commercial impact.
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The seizure risk for Acorda’s multiple sclerosis drug was already known, but an FDA MedWatch Alert based on post-market adverse event reports says, “the majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures.”