Rockwell Medical has a reputation as an industry innovator with an extensive history of product development and successful new product launches, addressing unmet needs in the renal market since its founding in 1994. It recently commercially launched Triferic® (ferric pyrophosphate citrate), the first and only water-soluble iron drug in the world delivered via dialysate, to replace iron and maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. The approval and commercialization of Triferic was based upon the results of a successful 11-year FDA clinical development program that included: two (2) in vitro primary pharmacodynamics studies, five (5) safety pharmacology studies, four (4) chronic-repeat-dose general toxicity studies, three (3) genotoxicity studies, six (6) reproductive and developmental toxicology studies, six (6) Phase I and 2 clinical studies and three (3) randomized, controlled, Phase 3 studies. In total, more than 100,000 doses of Triferic were safely administered as part of the clinical development program.
Building upon that success, Rockwell is now developing new Triferic formulations targeting the treatment of iron deficiency anemia in other renal and cancer markets. These formulations include: Triferic IV Solution for chronic or acute care intravenous use; Triferic TPN Solution for total parenteral nutrition acute care applications; Triferic PD Solution for peritoneal dialysis in the home; and Triferic Orphan indication to treat iron-refractory, iron-deficiency anemia (IRIDA).
In addition to Triferic, Rockwell has received FDA approval to market Calcitriol IV Injection, the lowest cost, lowest dose active form Vitamin D to treat secondary hyperparathyroidism (SHPT) in dialysis patients. The 1 mcg dose injection packaged in vials is designed to be cost effectively administered during each dialysis session. Calcitriol is more potent than branded Vitamin D drugs and is shown to be therapeutically equivalent in safety and efficacy to these agents.