Antares Pharma, Inc. (NASDAQ: ATRS) today announced positive results from an open-label, randomized, crossover study comparing the systemic availability of MTX Medi-Jet to oral methotrexate (MTX) in adult patients with rheumatoid arthritis (RA).
This study was designed to compare the relative systemic availability of MTX following oral administration to subcutaneous (SC) self-administered MTX using the Medi-Jet device. Patients were assigned to one of four dose levels of MTX, 10 mg, 15 mg, 20 mg, and 25 mg. Results showed that the systemic availability of methotrexate following oral dosing plateaus above 15 mg. Following administration of MTX with Medi-Jet, the systemic availability increased proportionally at every dose, which will extend the range of exposure compared to patients receiving oral therapy.
Historically, parenteral MTX use has been limited in clinical practice for several reasons including the inconvenience of weekly injections by a healthcare professional, and/or the challenges associated with teaching patients with impaired hand function, safe and sterile self-injection techniques. To address these issues, the easy to use, single-use MTX Medi-Jet auto injector was developed to optimize the clinical benefit of MTX, leading to cost effective treatment outcomes.
Dr. Lee S. Simon, Co-managing Director SDG LLC, stated, “Methotrexate has become the gold standard for first line disease modifying drugs used in the treatment of rheumatoid arthritis. Understanding how to optimize methotrexate therapy for better patient outcomes has become increasingly important.” Dr. Simon continued, “Treating to target in relation to biologic therapies, so that patients can achieve a low activity state of disease is optimal, and it is now time to address this same idea with methotrexate taking advantage of the MTX Medi-Jet to improve patient care.”
“Greater exposure to MTX when administered with MTX Medi-Jet could enhance the efficacy with improved response to disease control,” said Kaushik J. Dave R.Ph., Ph.D., Executive Vice President Product Development.