
The world's first drug to combat severe frostbite has been approved
The US Food and Drug Administration (FDA) has approved the first drug to combat severe frostbite. The drug Aurlumyn (iloprost) showed its effectiveness in clinical trials involving 47 people.
Aurlumyn (iloprost) is a vasodilator drug where active ingredient is iloprost - the synthetic analogue of prostacyclin PGI2. Iloprost improves blood flow to tissues, inhibits platelet aggregation and reduces high blood pressure. In 2004, iloprost was approved for the treatment of pulmonary arterial hypertension (PAH). At that time, it was the first inhaled drug for the treatment of PAH in the United States. In 2017, the development of an injectable dosage form with iloprost began to combat frostbite.
As part of a clinical study of the use of iloprost to combat severe frostbite, patients were divided into three groups:
- Patients of the first group were administered iloprost intravenously for 6 hours for 8 days.
- Patients of the second group took other drugs not approved for use in frostbite + iloprost.
- Patients of the third group took other drugs.
All participants also received intravenous aspirin and standard care for frostbite.
On the seventh day of therapy, none of the 16 patients receiving iloprost alone required amputation. Nine of 15 subjects in the group receiving the unapproved drug + iloprost also eliminated the need for amputation.
Eicos, which owns the rights to Aurlumyn, is also exploring the use of iloprost as a treatment for circulatory disorders, extracorporeal membrane oxygenation and systemic scleroderma (a condition that can lead to amputation).
Three iloprost preparations are registered in Russia, which are inhalation solutions intended for the treatment of PAH. Two out of three registration certificates belong to Russian companies. One is German.