First FDA-Approved Treatment for Severe Frostbite Now Commercially Available in the US

SERB Pharmaceuticals announced that Aurlumyn™ (iloprost) Injection, the first FDA-approved treatment for severe frostbite in adults to reduce the risk of digit amputations, is now commercially available in the US.

Aurlumyn ™ is available through specialty distribution by FFF Enterprises Inc.

Aurlumyn™ will be formally launched during this week’s American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting & Exhibition.

Dr. Jennifer Dow, Emergency Medicine physician at Alaska Regional Hospital and Medical Director for the Alaska Region of the National Park Service, said: “This marks a significant milestone in the field of frostbite treatment in the United States, and represents a new era of hope for patients at risk of digit amputations. Frostbite can be a debilitating condition that can lead to devastating consequences for patients. We hope Aurlumyn ™ will revolutionize the standard of care and provide physicians with an essential tool to treat this condition and reduce the risk of amputations."

Thomas Kolaras, Executive Vice President and US Chief Commercial Officer, said: "We are proud to make Aurlumyn™ available to hospitals, first responders, and military customers in the US. This treatment empowers healthcare professionals to act decisively in critical moments, delivering hope and effective care to those at risk of life-altering complications."

Studies show that thousands of people are hospitalized with frostbite in the US each year. This rare but highly debilitating condition most often affects winter sports enthusiasts, military personnel, outdoor workers, and the unhoused. Frostbite is a high morbidity, high-cost injury that can lead to digit or limb necrosis requiring amputation. Aurlumyn™ is indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations.

The most recent Wilderness Medical Society Clinical Practice Guidelines for the Prevention and Treatment of Frostbite strongly recommends considering Aurlumyn™ as a first-line therapy for Grades 3 and 4 frostbite <48 hours after thawing, and possibly for up to 72 hours.

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