Antares Pharma has reported disposable pressure-assisted auto injector Vibex methotrexate (MTX) study positive results.
The Vibex is designed for subcutaneous self-injection of MTX in rheumatoid arthritis (RA) patients at home.
The study has assessed several dose strengths of Vibex MTX versus subcutaneous or intramuscular injection using a conventional needle and syringe.
The study met the primary end points with all three methods of administration providing equivalent performance in the patients studied, together with comparable safety.
The safety for patients is increased through the use of an integrated, shielded needle and lockout system which prevents accidental needle-sticks after use.
Antares Pharma president and CEO Paul Wotton said that they have completed this clinical pharmacokinetic study with positive results and plans to file a new drug application (NDA) with the US Food and Drug Administration (FDA) in 2012.
"We will continue to focus our efforts on commercializing injectable products designed to improve patient care and provide therapeutic benefits," Wotton said.