Cumberland Pharmaceuticals Intends To File New Drug Application To FDA For Ifetroban To Treat Cardiomyopathy Associated With Duchenne Muscular Dystrophy

Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX), ("Cumberland" or the "Company") an innovation-focused biopharmaceutical company developing new products for rare diseases, today provided an update on its ifetroban product candidate in development as a potential treatment for the cardiomyopathy associated with Duchenne muscular dystrophy ("DMD"). The Company announced plans to submit a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for ifetroban as a potential treatment for the cardiomyopathy associated with DMD.

Cumberland requested a pre-NDA meeting with FDA, which was held this fall. During the pre-NDA meeting, the discussions involved the format and content and of the planned submission including the needed reports and requested analysis. Cumberland is proposing the FIGHT DMD™ trial as the pivotal study to be combined with comparison data from two natural history databases to support product approval. Following the meeting FDA granted the Company's request for a rolling review of the NDA, which allows completed sections of the application to be provided to the FDA for review, prior to the submission of the entire application.