S. Harhen, T. Gardner, J. Walsh
Rx Bandz, New Jersey, United States
Keywords: TXA, Hemorrhage, Auto-Injector
Rx Bandz has developed a high-strength concentrated Tranexamic Acid (TXA) formulation for intramuscular injection (IM). Our recent bioavailability, pharmacokinetics, and cellular histopathology study in large swine, a milestone deliverable of a Phase II Military Contract, yielded promising results. The intramuscular administration of TXA achieved blood levels 116% higher than intravenous (IV) administration. The recommended effective availability occurred within 10 minutes after IM injection and sustained optimal therapeutic levels throughout the 360-minute experiment. In contrast, IV administration initially spiked to dangerously high levels and fell below the optimal range only after 250 minutes. Our study design allowed us to administer both IV and IM doses to the same swine, with complete clearance between doses, ensuring accurate comparisons and eliminating potential variables. Additionally, the injection site evaluation indicated minimal localized impact, further supporting the promising nature of our formulation. We are confident that our team's expertise and the traction achieved thus far demonstrate the potential of our high-strength concentrated TXA formulation for IM injection as an effective and convenient alternative to IV administration, offering sustained therapeutic levels and reduced adverse effects.