The Biomedical Advanced Research and Development Authority (BARDA) awarded Rafa Laboratories a landmark development contract valued at up to $186 million. This significant BARDA contract mandates the advanced development of a novel intramuscular (IM) formulation of tranexamic acid (TXA), a critical life-saving therapy used to control severe, uncontrolled bleeding. The partnership between the U.S. Department of Health and Human Services (HHS) agency and the biodefense specialist directly addresses the urgent global requirement for a rapidly deployable hemorrhage treatment in prehospital settings.
Addressing the Critical Window to Save Lives
Uncontrolled bleeding remains the leading preventable cause of death following trauma, whether stemming from accidents, mass-casualty events, or battlefield injuries. TXA, an antifibrinolytic agent, significantly reduces mortality rates when caregivers administer it quickly after a hemorrhagic injury. However, current administration typically requires an intravenous (IV) line, which is challenging, time-consuming, and requires specialized training, making it exceptionally difficult in high-stress or remote environments.
Rafa Laboratories tackled this challenge by focusing on an easy-to-use intramuscular solution, aiming to develop a TXA autoinjector. This innovative device will enable nonprofessional and professional caregivers alike to deliver the essential treatment instantly. The IM route offers a fast, reliable, and user-friendly alternative to the existing IV method, which often proves nearly impossible for patients experiencing severe shock. Development of the TXA autoinjector will dramatically increase survival chances worldwide by simplifying the process of immediate care. This extensive BARDA contract highlights the agency’s commitment to ensuring national preparedness through agile medical countermeasure development.
Path to [U.S. Food and Drug Administration] Approval
Under the terms of the agreement, Rafa Laboratories will execute a robust and integrated product development approach. The scope of work involves multiple crucial phases, including formulation development, manufacturing scale-up, and extensive preclinical and clinical trials. Ultimately, the comprehensive development plan aims to secure a streamlined regulatory pathway designed to achieve approval from the U.S. Food and Drug Administration (FDA). The collaboration strategically expands Rafa’s presence in acute trauma care, ensuring the delivery of this urgently needed life-saving solution to preparedness stockpiles across the globe.
