Antares’ VIBEX MTX trial meets primary endpoints
Antares Pharma has reported positive results of a clinical study evaluating VIBEX MTX, a proprietary auto injector product designed to give a rapid subcutaneous injection of methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). The clinical pharmacokinetic study evaluated several dose strengths of MTX delivered by a healthcare professional to RA patients with VIBEX MTX versus subcutaneous or intramuscular injection using a conventional needle and syringe. The primary end points were met with all three methods of administration providing equivalent performance in the patients studied, together with comparable safety.
VIBEX MTX is designed for rapid injection of subcutaneous MTX in three simple steps and is engineered to enable RA patients to self-inject reliably, comfortably, and conveniently at home. Safety for patients is enhanced through the use of an integrated, shielded needle and lockout system which prevents accidental needle-sticks after use. The availability of VIBEX MTX could give physicians a new option to optimize both patient treatment and the use of biological agents in RA. VIBEX MTX is protected by several issued and pending patents.
Paul K. Wotton, president and CEO, commented, "I am pleased that we have completed this clinical pharmacokinetic study with positive results and that we remain on track to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in 2012. Patient interviews following the studies indicated that the VIBEX MTX product was comfortable and easy for patients to use and preferred over a conventional needle and syringe."