First SC Methotrexate Auto-Injector Approved

Antares Pharma announced that the FDA has approved Otrexup (methotrexate) injection, the first subcutaneous (SC) methotrexate for once-weekly self-administration with a single-dose, disposable auto-injector. Otrexup features the VIBEX Medi-Jet proprietary technology , an easy-to-use parenteral drug delivery system that incorporates an integrated, shielded needle.

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Otrexup  is indicated for the management of adults with severe, active rheumatoid arthritis (RA) and children with polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy and the symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.

Clinical study data demonstrated increased bioavailability of SC methotrexate compared to oral methotrexate at every dose. These findings confirm and strengthen data of previously published bioavailability studies, and highlight the saturable limitations of oral methotrexate that result in a bioavailability plateau at 15mg.

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Otrexup will be available as a single-dose auto-injector (0.4mL) in 10mg, 15mg, 20mg, and 25mg dosage strengths. Otrexup is expected to be available in January 2014.

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