Drugs Health Pharma

US regulator gives green light for first-ever drug for severe frostbite

HQ Team

February 16, 2024: The U.S. Food and Drug Administration (FDA) has approved the first-ever drug, iloprost, to treat severe frostbite in adults, which will reduce the risk of amputations. The drug will be sold under the brand name Aurlumyn by Eicos Sciences Inc

“This approval provides patients with the first-ever treatment option for severe frostbite,” said Norman Stockbridge, M.D., Ph.D., 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 lifechanging amputation of one’s frostbitten fingers or toes.”

Frostbite can happen when a person is exposed to extremely cold temperatures. It leads to a loss of feeling in the areas it affects, usually extremities such as the nose, ears, cheeks, chin, fingers, and toes. Frostbite can permanently damage the body, and severe cases can lead to amputation 

Iloprost, the active ingredient in Aurlumyn, prevents blood from clotting and improves blood circulation.

Drug efficacy

In a controlled trial 47 adults with severe frostbite were placed in three random groups, and each was treated with aspirin by vein and standard of care. Group 1 received iloprost for 6 hours daily for up to 8 days. The two other groups received other medications unapproved for frostbite, given with iloprost (Group 2) or without iloprost (Group 3). 

After a week, the efficacy of iloprost was measured with a bonescan to predict the need for amputation.

The group that received iloprost alone saw 0% need for amputatuion (none out of 16) compared to 19% (3 out of 16) and 60% in Group 2 and 3 (9 out of 15), respectively. 

The presence of the bone scan abnormality was significantly lower in the two groups receiving iloprost. A followup was done on patients who needed an amputation later on. The results were in consonance with the bone scan findings.

Side effects

According to the researchers, the most common side effects of Aurlumyn include headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness, and hypotension (low blood pressure). 

Aurlumyn received Priority Review and Orphan Drug designations for this indication.

Iloprost was originally approved in 2004 for the treatment of pulmonary arterial hypertension.



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