(Reuters) - The U.S. Food and Drug Administration on Wednesday approved Eicos Sciences' injection, making it the first-ever treatment to treat severe frostbite in adults.
The treatment, which will help reduce the risk of amputation, will be sold under the brand name Aurlumyn and is expected to be available in Spring 2024, although its pricing has not yet been determined, the company said in an e-mailed statement.
Iloprost, the active ingredient in Aurlumyn, opens blood vessels and prevents clotting. It was originally approved in 2004 for the treatment of pulmonary arterial hypertension.
Aurlumyn comes with a warning and precaution noting that it may cause symptomatic hypotension.
Frostbite can occur in several stages. Mild frostbite is usually treated with painkillers and antibiotics.
Severe frostbite, when both the skin and underlying tissue are frozen and blood flow stops, sometimes requires amputation.
Patients were divided into three treatment groups in the trial. All were administered aspirin by vein and standard of care while two groups received iloprost.
The primary measure of efficacy was a bone scan obtained seven days after initial frostbite that was used to predict the need for amputation of at least one finger or toe.
On day seven, the need for amputation was observed in none of the 16 patients receiving iloprost alone, compared with 3 of 16 patients and 9 of the 15 patients on medications unapproved for frostbite, given with iloprost or without iloprost.