Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that the U.S. Food & Drug Administration (FDA) has approved the New Drug Application for Triferic Powder Packet for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease. Triferic is the Company's innovative iron-replacement drug for the treatment of anemia in chronic kidney disease patients receiving hemodialysis.
"We are pleased to obtain this FDA approval for the Triferic powder packet," stated Robert L. Chioini, Founder, Chairman and Chief Executive Officer of Rockwell. "Our mind-set is to continually improve, and this new Triferic presentation is a fine example. The Triferic powder packet is similar to the size of a packet of sugar. It is much smaller and lighter than the current Triferic liquid ampule and it enables us to place three-times greater the number of units in an even smaller carton. This presentation is much more convenient for customers as it reduces storage space and requires fewer reorders to maintain inventory. We expect it to be commercially available shortly."
Triferic is an innovative iron replacement product that is delivered to hemodialysis patients via dialysate, replacing the ongoing iron loss that occurs during their dialysis treatment. Triferic is added to the bicarbonate concentrate on-site at the dialysis clinic. Once in dialysate, Triferic crosses the dialyzer membrane and enters the blood where it immediately binds to transferrin and is transported to the erythroid precursor cells to be incorporated into hemoglobin. Triferic delivers sufficient iron to the bone marrow and maintains hemoglobin without increasing iron stores (ferritin).
