Rockwell Medical Submits Supplemental Data to FDA for IND Application for Phase 2 FPC Home Infusion Trial

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[{"type":"text","content":"WIXOM, Mich., May 12, 2022 /PRNewswire/ -- Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management, today announced that it provided the U.S. Food and Drug Administration (FDA) with the supplemental data, requested by the agency in December 2021, for the Company's pending Investigational New Drug (IND) application in support of a proposed Phase 2 clinical trial of Ferric Pyrophosphate Citrate (FPC) for the treatment of iron deficiency anemia and maintenance of hemoglobin in patients receiving infusion therapy in the home setting. The additional data relate to the physical, chemical and microbiological stability of FPC in support of the suggested method of administration in the Phase 2 protocol. \n\n \n \n \n \n \n \n\n \nHome Infusion, where various medications are given via infusion therapy in the home, rather than an infusion center, is a rapidly-growing segment of home healthcare. Many patients that are receiving infusion therapy at home suffer from diseases that are associated with iron deficiency, which is difficult to treat with traditional forms of iron. \n \"We are pleased to provide the FDA with the additional data it requested to support our IND for FPC in patients undergoing infusion therapy at home,\" said Russell Ellison, M.D., M.Sc., President and CEO of Rockwell Medical. \"This is an iterative process with the FDA as this is the first clinical trial of parenteral iron in the treatment of iron deficiency anemia in the home setting, with the goal of enabling patients to avoid visits to a doctor's office or clinic to receive iron, which would represent a significant improvement in the care of these patients. We remain confident in the potential of FPC and are prepared to move forward with the initiation of the Phase 2 trial, pending the review and clearance of our IND\"\nThe FDA has 30 days to review the additional data that have been submitted. In the event that the FDA has no further questions or requirements regarding the submission, the Company would expect the trial to start shortly after the review period ends.\nAbout Rockwell MedicalRockwell Medical is a commercial-stage biopharmaceutical company developing and commercializing its next-generation parenteral iron technology platform, Ferric Pyrophosphate Citrate (FPC), w...

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