“We are extremely pleased with the results of the Actual Human Use study,” said Kaushik J. Dave R.Ph., Ph.D., and Executive Vice President Product Development. “The study demonstrated that rheumatoid arthritis patients were able to successfully self-administer MTX with the VIBEX Medi-Jet which we believe is safe, well tolerated and easy to use. These study results along with the positive Usability Study results previously reported in patients with severe to very severe hand function impairment keep us on schedule for an early 2013 filing of the New Drug Application for VIBEX MTX, a potential new treatment option for patients who suffer with RA.”
About VIBEX Medi-Jet and Methotrexate
VIBEX Medi-Jet is a proprietary parenteral drug delivery system protected by several issued and pending patents. VIBEX Medi-Jet is designed to enable patients to quickly and easily self-administer a drug subcutaneously or intramuscularly, reliably and comfortably while also enhancing safety with an integrated, shielded needle that protects against accidental needle stick and drug exposure. VIBEX and Medi-Jet are trademarks of Antares Pharma.
Methotrexate is a commonly prescribed disease-modifying anti-rheumatic drug (DMARD), used in an estimated 70% of rheumatoid arthritis patients either on its own or in combination with biological therapies. Methotrexate is started at a low dose, generally 7.5mg given orally, once-a-week, and titrated up for greater therapeutic effect, or until the patient incurs side effects. The maximum oral dose given is generally 20mg to 25mg per week. Published studies have reported that 30% to 60% of patients experience gastrointestinal side effects with oral methotrexate, preventing further dose escalation or requiring discontinuation in some patients. Oral absorption of methotrexate varies considerably between patients and between doses in the same patient and has been shown to decline with increasing doses, which may also contribute to insufficient therapeutic response even after dose escalation. Switching patients from oral to parenteral methotrexate improves absorption and has been associated with improved therapeutic response. Additionally, some studies have shown a lower incidence of gastrointestinal side effects in patients that were switched from oral to parenteral methotrexate.