Antares Pharma announced that the FDA has accepted for review their New Drug Application (NDA) for Otrexup, a potential new product for the SQ delivery of methotrexate (MTX) using Medi-Jet technology. Otrexup is being developed for self-administration of MTX to enhance the treatment of rheumatoid arthritis (RA), polyarticular-course juvenile RA and psoriasis.
Medi-Jet is a proprietary parenteral drug delivery system designed to enable patients to quickly and easily self-administer a drug SQ or IM, with a shielded needle that protects against accidental needle stick and drug exposure. Methotrexate is a disease-modifying anti-rheumatic (DMARD), for the treatment of RA, used in patients either on its own or in combination with biological therapies.
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