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Cumberland receives FDA orphan, RPDD designation for Ifetroban
The Fly

Cumberland receives FDA orphan, RPDD designation for Ifetroban

Cumberland (CPIX) Pharmaceuticals announced that the United States FDA granted Orphan Drug Designation and Rare Pediatric Disease Designation to Ifetroban for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy. Cumberland is completing the FIGHT DMD trial, a multicenter, double-blind, placebo-controlled Phase II study investigating the pharmacokinetics, safety and efficacy of once daily oral Ifetroban in patients with DMD. Results will be announced later this year.

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