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

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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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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.

Ampyra Trial Failure Is Not All Bad News For Acorda

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.

Ampyra Trial Failure Is Not All Bad News For Acorda

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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