Over the last month, for those watching HBO’s macabre “True Detective: Night Country”—a TV series set in a harsh, sunless winter in a fictional Alaskan town—a continual theme is frostbite.
So the timing is right for the FDA to approve the first medicine for severe frostbite, which is caused by exposure to extreme cold. The U.S. regulator has signed off on Eicos Sciences' Aurlumyn (iloprost), an injected treatment to combat severe cases of frostbite in adults and reduce their risk of amputation of the fingers or toes.
As a vasodilator, iloprost opens blood vessels and prevents blood from clotting. In 2004, the drug, which was originally developed by California company CoTherix, won an approval to treat pulmonary arterial hypertension (PAH). Known commercially as Ventavis, it was then the only inhaled therapy for PAH in the U.S.
Eicos, which is a subsidiary of California-based CiVi Biopharma, has reformulated iloprost into an injected treatment, developing it for frostbite since the inception of the company in 2017.
Maryland-based Eicos also is investigating iloprost as a treatment for a circulation disorder, extracorporeal membrane oxygenation (ECMO), and for systemic sclerosis, another disease that can leave patients at risk of amputation of their fingers or toes.
Aurlumyn’s endorsement is based on a trial of 47 adults with severe frostbite who were split into three groups. One received iloprost intravenously for six hours daily for up to eight days. The two other groups received other medications that are unapproved for frostbite, with one of the groups also receiving iloprost and the other not.
Bone scans taken seven days after initial frostbite—which are used to determine the need for amputation of fingers or toes—found that zero of 16 patients who used iloprost alone needed amputation.
As for the other groups, three of 16 patients who received iloprost and an unapproved medication required amputation, while nine of 15 of those in the group that did not receive iloprost needed 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, the FDA said.
Severe frostbite removes all sensation of cold or discomfort and can cause muscles and joints to stop working. It can affect all layers of the skin, with blisters forming 24 hours after exposure and tissues turning black as they die, according to the Mayo Clinic.
Editor's note: The original version of this story, based on a release from the FDA, credited Johnson & Johnson as the owner of Aurlumyn (iloprost).