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Ampyra Trial Failure Is Not All Bad News For Acorda

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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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Ampyra Seizure Warnings Strengthened Followed Continued Reports

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.”

The Long Road To Approval: Acorda Experience With Ampyra Shows Success Of Novel Analysis Plan

Acorda Therapeutics' challenges in seeking approval for its oral therapy Ampyra to improve walking ability in patients with multiple sclerosis were greater than most from the start: it was a novel drug for a first-of-its-kind claim – and the drug yielded variable efficacy on an unproven endpoint. What seems to have made the difference is the creative analysis plan that Acorda came up with.

Everything Old Is New Again: History Of Compounding Shaped Ampyra REMS

Acorda’s Ampyra (dalfampridine) is a first-in-class new molecular entity in terms of FDA approval, but the drug substance’s history as a compounded drug raised the concerns necessitating a Risk Evaluation and Mitigation Strategy, FDA’s review documents show.

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