The administration of Injectafer, an iron replacement therapy, was shown to safely help manage fibromyalgia symptoms when compared to a placebo in patients with iron deficiency, according to data from a Phase 2 clinical trial.
The findings were reported in the study, “A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ferric Carboxymaltose in Iron-Deficient Patients with Fibromyalgia,” published in the journal Rheumatology and Therapy.
Fibromyalgia is characterized by widespread, chronic pain together with several other symptoms, including fatigue, depression, anxiety, and stiffness. It is still unclear what causes fibromyalgia, but studies have suggested that abnormal responses by the central nervous system may contribute to fibromyalgia symptoms.
A previous study revealed that fibromyalgia was a common feature presented by patients with iron-deficiency anemia and thalassemia minor. In addition, patients with low levels of iron have a 5.6 times higher risk of developing fibromyalgia. It is common for patients with fibromyalgia to have lower levels of iron compared to healthy individuals.
Taken together, these data suggest that iron could play a role in the development of fibromyalgia and that iron supplements could potentially be a therapeutic option for these patients.
Now, in a Phase 2 trial (NCT02409459), researchers tested the safety and effectiveness of iron replacement therapy with Injectafer (ferric carboxymaltose) for the treatment of iron deficiency in patients with fibromyalgia.
Injectafer was developed by Luitpold Pharmaceuticals to mimic the response of natural iron. It is a complex iron formulation that was approved by the U.S. Food and Drug Administration (FDA) in 2013 for the treatment of iron-deficiency anemia in adult patients who do not respond well to oral iron or have non–dialysis-dependent chronic kidney disease.