Rockwell Medical Presents Data on Diagnosis and Management of Iron Deficiency Anemia in Home Parenteral Nutrition Patients at the NHIA 2021 Annual Conference

WIXOM, Mich., April 22, 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 that it presented data from a clinical feasibility study reviewing the practice patterns of iron deficiency anemia (IDA) in home parenteral nutrition patients at the National Home Infusion Association’s (NHIA) 2021 Annual Conference, taking place virtually from April 19 to 22, 2021.

“The study results validated our initial assumptions that management of iron deficiency anemia in this home infusion population is suboptimal and remains an unmet clinical need. Although approximately half of the patients in the home infusion setting suffer from iron deficiency anemia, and oral iron is indicated as a first-line therapy, many patients may not tolerate it, or may have unsatisfactory results with this option,” said Marc L. Hoffman, M.D., Chief Medical Officer of Rockwell Medical and study author. “Traditional forms of IV iron are rarely administered unsupervised in the home due to risk of hypersensitivity reactions or concerns about incompatibility with other medications, and office visits for infusion of IV iron are costly, inconvenient, and often do not fit the physician practice care model.”

Key findings include the following insights:

• More than 85% of physicians and pharmacists would recommend intravenous (IV) iron for home parenteral nutrition patients.
• Oral iron remains first-line therapy in ~50% of respondents in both groups.
• Standard iron panel (Fe, TIBC, ferritin, TSAT) is employed in the home infusion setting for assessment of iron status.
• Validation of literature reports that approximately 50% of home parenteral nutrition patients suffer from IDA, however:
  • There is no clear consensus on treatment or practice patterns;
  • No clear consensus for hemoglobin target to initiate therapy; and
  • No clear consensus from outreach for hemoglobin target for goal-directed therapy.
• Existing treatment plans are indicative of the current therapeutic options available.

Dr. Hoffman added: “Rockwell Medical plans to initiate the first-ever well-controlled randomized clinical trial to evaluate the safety and efficacy of a parenteral iron treatment, in this case FPC, delivered at home. The proposed study design incorporates the considerable knowledge and data that already exist for the FPC molecule, including an extensive safety database of more than 1.3 million administrations in a very frail hemodialysis patient population, and well-established kinetics that provide strong rationale for the doses and dose schedules that have been developed for this setting. We look forward to our upcoming pre-IND meeting with the FDA.”