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.
Cumberland's decision to submit the NDA followed an End-of-Phase 2 meeting with FDA in September 2025 and a follow-up Type C meeting in January 2026. FDA suggested a Phase 3 trial and raised several issues regarding the Phase 2 study results including the suitability of the LVEF endpoint, comparator related questions and the development of the statistical analysis plan. In response, the Company provided additional data supporting its efficacy findings, natural history data from a second DMD registry, and documentation of how the statistical analysis plan was developed.
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