Philadelphia, PA, Dec. 09, 2024 (GLOBE NEWSWIRE) -- SERB Pharmaceuticals, a global specialty pharmaceutical company, is proud to announce 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.[i]
Aurlumyn ™ is available through specialty distribution by FFF Enterprises Inc. Customers interested in ordering can call 1-800-843-7477 or visit https://biosupply.fffenterprises.com.
Aurlumyn™ will be formally launched during this week's American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting & Exhibition. ASHP meeting attendees can learn more about Aurlumyn ™ by visiting booth 339.
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.[ii] 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.[iii] 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.
About SERB Pharmaceuticals
SERB is a global specialty pharmaceutical company with a growing portfolio of medicines for emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. SERB is a leading provider of essential acute care medicines, addressing unmet medical needs and supplying antidotes and medical countermeasures for chemical, biological, radiological and nuclear (CBRN) risks. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain.
Learn more at https://SERB.com
About Aurlumyn™ (OR-LOO-MIN)
Aurlumyn™ is a prostacyclin mimetic and acts as a vasodilator (a drug that opens blood vessels) and inhibits platelet aggregation. Aurlumyn™ is indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes.[iv] Aurlumyn™ was granted priority review and orphan drug designation (ODD) and was approved by the FDA in February of 2024 for the treatment of severe frostbite in adults to reduce the risk of digit amputations. A published case series review showed that Aurlumyn™ can be effective up to 72 hours after rewarming of a frostbite patient begins.
Learn more at: https://aurlumyn.com/
For further information contact:
Chris Sampson, Director of Corporate Communications
[email protected]; Tel: +44 (0)7773 251 178
INDICATIONS AND USAGE
AURLUMYN is a prostacyclin mimetic indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
AURLUMYN may cause symptomatic hypotension. Correct hypotension prior to administration of AURLUMYN. Monitor vital signs while administering AURLUMYN.
Adverse Reactions
Adverse events reported with the use of intravenous (IV) iloprost in patients with frostbite include headache, flushing, palpitations/tachycardia, nausea, vomiting, dizziness, and hypotension.
Use in Specific Populations
- Advise women not to breastfeed during treatment with AURLUMYN.
- The safety and efficacy of AURLUMYN in pediatric patients have not been established.
- Dosage adjustment is recommended in patients with moderate or severe hepatic impairment
- In patients with eGFR <30 mL/min, dosage adjustment can be considered based on tolerability. The effect of dialysis on the clearance of AURLUMYN has not been evaluated.
Please see Full Prescribing Information.
US-AUR-2400046
[i] Aurlumyn Prescribing Information
[ii] Endorf FW, Nygaard RM. Social Determinants of Poor Outcomes Following Frostbite Injury: A Study of the National Inpatient Sample. J Burn Care Res. 2021 Nov 24;42(6):1261-1265. doi: 10.1093/jbcr/irab115. PMID: 34139760.
[iii] Endorf FW, Nygaard RM. High Cost and Resource Utilization of Frostbite Readmissions in the United States. J Burn Care Res. 2021 Sep 30;42(5):857-864. doi: 10.1093/jbcr/irab076. PMID: 33993288.
[iv] Cauchy E, Cheguillaume B, Chetaille E. A controlled trial of a prostacyclin and rt-PA in the treatment of severe frostbite. N Engl J Med. 2011 Jan 13;364(2):189-90. doi: 10.1056/NEJMc1000538. PMID: 21226604.
CONTACT: Chris Sampson
SERB Pharmaceuticals
+44 7773 251 178
