Benzinga | Nov 16, 2021 04:03PM EST

Rockwell Medical Highlights Publication Of Results In 'Journal Of Bioquivalence & Bioavailability' Showing No Drug-Drug Interaction Between Ferric Pyrophosphate Citrate, Unfractionated Heparin

Findings confirm results from previous population PK study demonstrating safe and effective anticoagulation along with the delivery of Ferric Pyrophosphate Citrate iron

WIXOM, Mich., Nov. 16, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced the publication of results in the Journal of Bioequivalence & Bioavailability from a study designed to investigate the co-administration of intravenous (IV) Ferric Pyrophosphate Citrate (FPC, Triferic(r)) with unfractionated heparin (UFH) as an admixture via the HD-machine syringe pump. The study demonstrated no clinically relevant drug-drug interaction between FPC and UFH on the effects of UFH nor on the ability of FPC to deliver bioavailable iron when these agents are co-administered as a single admixture via an HD-machine syringe pump.

"These findings are significant because they demonstrated no clinically relevant drug-drug interaction between FPC and unfractionated heparin, the latter of which has long been the standard to provide anticoagulation in patients on hemodialysis," said Marc Hoffman, M.D., Chief Medical Officer of Rockwell Medical. "Furthermore, the findings confirm results of a previous study which used a population pharmacokinetic model for anti-Xa activity to confirm the effective anti-coagulation dose of UFH and are consistent with our clinical experience of FPC in the real-world setting, in which more than 1.6mm million doses have been safely administered."

The prospective, single-center, open-label, three-period, crossover trial was conducted to investigate the ability of an FPC/UFH admixture to maintain adequate anticoagulation of the dialyzer circuit and to assess the impact of administration of the admixture on the iron delivery of FPC in patients with Hemodialysis Dependent Chronic Kidney Disease (HDD-CKD). The study investigated three treatment regimens in randomized sequence. Anti-Xa activity, activated prothrombin time (aPTT), Thrombin time (TT) and serum iron parameters were measured. Pharmacokinetics and pharmacodynamics were determined using non-compartmental methods and comparisons of Cmax and AUC were calculated using a standard bio-equivalence approach.

The study found that mean anti-Xa activity, activated prothrombin time (aPTT), Thrombin time (TT) concentrations were comparable across all timepoints at baseline, and throughout the study. The concentration-time profiles for iron and TSAT were the same between the FPC/UFH admixture and FPC/UFH administered by separate routes. FPC and UFH were well tolerated with no reported adverse events.

FPC is FDA-approved in the United States for the replacement of iron to maintain hemoglobin in adult patients with HDD-CKD. FPC may be administered in the dialysate or as a slow continuous IV infusion over three to four hours via the pre dialyzer infusion line, via the post-dialyzer infusion line, or via a separate connection to the venous blood line during hemodialysis. In vitro drug-drug interaction studies have demonstrated that FPC can be admixed with unfractionated heparin and retain its pharmacodynamic effect for up to 24 hours.