FDA approves first-ever medication for severe frostbite treatment

The U.S. Food and Drug Administration (FDA) has approved Aurlumyn (iloprost) injection for treating severe frostbite in adults, aiming to decrease the risk of finger or toe amputation.

Frostbite can occur in several stages, ranging from mild frostbite that does not require medical intervention and does not cause permanent skin damage, to severe frostbite when both the skin and underlying tissue are frozen and blood flow is stopped, sometimes requiring amputation.

Iloprost, the active ingredient in Aurlumyn, is a vasodilator (a drug that opens blood vessels) and prevents blood from clotting implying that it is beneficial in reducing blood pressure and improving blood flow to frozen fingers and toes. It a synthetic analogue of prostacyclin and was first developed by researchers seeking a treatment for vascular disorders and was initially investigated for its vasodilatory properties and potential therapeutic benefits in conditions such as pulmonary hypertension and peripheral vascular disease.

Iloprost's mechanism of action involves activating prostacyclin receptors, leading to vasodilation, inhibition of platelet aggregation, and other beneficial effects on vascular function. These actions make it a valuable therapeutic option for various vascular disorders.

For the study iloprost was administered intravenously in 47 adults with severe frostbite for up to 8 days alongside aspirin and standard care. Compared to other medication groups, iloprost alone showed significant efficacy in preventing bone scan abnormalities predictive of amputation. Specifically, none of the patients receiving iloprost alone required amputation, contrasting with 19% and 60% of patients in the other groups, respectively.

“This approval provides patients with the first-ever treatment option for severe frostbite,” said Dr. Norman Stockbridge, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. “Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one’s frostbitten fingers or toes.”