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Imagine scaling a mountain only to later lose digits or an entire hand to the unforgiving ravages of frostbite. For climbers, explorers, adventurous backcountry skiers, and even those caught in unexpected winter storms, severe cold exposure carries a devastating risk — amputation. Today, thanks to a potentially landmark FDA approval, the prospect of losing one’s extremities to frostbite becomes slightly less chilling.
Novel indication for iloprost
Eicos Sciences’s Aurlumyn, containing the active ingredient iloprost, offers a novel approach to treating severe frostbite. Iloprost, a synthetic version of a naturally occurring substance known as prostacyclin, targets two key problems. First, it addresses cold-induced blood vessel construction by widening them to restore essential blood flow to the affected tissues. Second, it prevents blood clots from forming, which can further block circulation and lead to tissue death.
The approval of iloprost for frostbite rests on data from a randomized, open-label study involving 47 patients with severe frostbite published in NEJM in 2011. The results of the trial showed that patients who received iloprost had a significantly lower risk of amputation compared to those who received other therapies. Additionally, the presence of bone scan abnormality — an indicator of severe tissue damage — was significantly lower among patients who received iloprost.
Historical precedent for FDA approval of Aurlumyn for frostbite
The success of Aurlumyn — intravenous iloprost — against frostbite isn’t entirely surprising. Researchers have explored iloprost’s properties, primarily its ability to drive vasodilation and stop clotting in the treatment of pulmonary arterial hypertension (PAH). In PAH, where high blood pressure constricts arteries from the heart to the lungs, these traits have established it as “one of the most effective drugs for the treatment of pulmonary arterial hypertension,” as a 2010 article in the Texas Heart Institute Journal noted.
Eicos Sciences expects the therapy to be available by spring 2024.
While Aurlumyn could shift the treatment landscape for frostbite, it has potential side effects. FDA notes that some patients may experience headaches, flushing, heart palpitations, or nausea. More seriously, the medication can also lead to abnormally low blood pressure (hypotension). The medication will bear a warning for symptomatic hypotension.