Imprimis Pharmaceuticals, which focuses on the commercialization of drug formulations utilizing the FDA drug development pathway, has acquired intellectual property for IPI-120, a novel drug formulation of both tranexamic acid, a synthetic derivative of the amino acid lysine, and an antibiotic. The company's recently-filed patent application combines tranexamic acid with an antibiotic to provide the clotting effects along with protection or treatment against infection in a transdermal, local intra-wound application or intra-cavity instillation formulation.
IPI-120 could help patients with genetic and acquired bleeding disorders. Lower strength IPI-120 formulations for OTC applications may also be used to stop bleeding and prevent or treat infection in common wounds, cuts and bruises.
Tranexamic acid, which is approved in intravenous and oral dosage forms, is frequently used in surgeries with high risk of blood loss such as cardiac, liver, vascular and large orthopedic procedures. Imprimis believes IPI-120 may be applied in targeted compromised populations of patients with bleeding disorders and may qualify as an orphan drug development candidate. IPI-120 was created by a pharmacist at Buderer Drug, a compounding pharmacy in Ohio, interested in offering a transdermal wound management product that not only acted as an antibiotic, but that also helped control bleeding.
"Control of bleeding and infection is an integral part of the wound healing process,” said Dr. Joachim Schupp, Imprimis’ chief medical officer. “The normal blood clotting process depends on the interplay of various proteins in the blood. Bleeding disorders may be caused by reduced levels or absence of blood-clotting proteins, known as clotting factors or coagulation factors. A reduction in those clotting factors is found in genetic disorders, such as hemophilia A, hemophilia B and von Willebrand disease. Bleeding disorders can also be acquired such as in end stage liver disease, acute leukemia or Vitamin K deficiency.”
The U.S. wound care market is expected to reach nearly $21 billion by 2015, from $16.8 billion in 2012. Seven million Americans suffer from chronic wounds and the market is expected to grow in part due to the aging population and ongoing proliferation of diabetes and other chronic illnesses.