Rockwell Medical ($RMTI) reported positive results in its clinical study of a system designed to more effectively deliver iron to patients during dialysis. Although the results were separate from FDA-required trials, Rockwell hopes to finish its Phase III study and apply for new drug status with the FDA by the end of this year.
Rockwell claims that its soluble ferric pyrophosphate (SFP) could be an alternative to intravenous iron therapy. For patients who undergo regular dialysis for kidney failure, SFP is the first iron supplement that is delivered along with the dialysate--currently, iron is administered separately. By delivering iron directly to the bone marrow, SFP mimics the way the body delivers it in a healthy person, replacing the iron lost during dialysis.
Rockwell Chief Scientific Officer Ajay Gupta told FierceDrugDelivery that SFP prevents the accumulation of iron in the liver, heart and other organs, which can occur during normal intravenous treatment due to a carbohydrate shell around the iron particles. SFP does away with the shell, reducing the risk of anaphylactic shock, Gupta said, as well as lowering significantly the dosage of harmful and expensive chemicals, such as erythropoietin-stimulating agents, or ESAs.
ESAs, though highly toxic, are used to stimulate red blood cell production during dialysis. The 9-month study showed that the needed amount of ESAs dropped 37% when using SFP, cutting the cost to providers, Rockwell CEO Robert Chioni told FierceDrugDelivery.
"For every 2% reduction in ESA levels, there's $1 of savings--so think about 37%," Chioni said of the estimated $600 million U.S. and $1 billion global markets. "This has the potential to enter a huge share of the market quickly."
Rockwell hopes to gain approval for SFP by the middle of 2014.
- here's the release