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ISSUE: OCTOBER 2013 | VOLUME: 40
Methotrexate Approved for Three Rheumatologic Conditions
Antares Pharma announced FDA approval of methotrexate (Otrexup) injection for the treatment of adults with rheumatoid arthritis, children with polyarticular juvenile idiopathic arthritis and adults with psoriasis.
Methotrexate is indicated for adults with severe active rheumatoid arthritis who have had insufficient therapeutic response to or are intolerant of an adequate trial of first-line therapy—including full-dose nonsteroidal anti-inflammatory agents—as well as children with active polyarticular juvenile idiopathic arthritis. The FDA also approved adult use of methotrexate for symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy.
Methotrexate treatment is usually initiated with oral tablets; however, many patients experience an inadequate response for reasons of efficacy or tolerability.
Human study data submitted to the FDA demonstrated increased bioavailability of subcutaneous methotrexate compared with oral methotrexate at every dose. Study investigators posited that these results confirm and strengthen the findings of previously published bioavailability data, and highlight the saturable limitations of oral methotrexate that result in a bioavailability plateau at 15 mg.
For more information, including full prescribing information, please visit WWW.antarespharma.com, or www.otrexup, or call (855) OTREXUP (855 687 3987).
—Based on a press release from Antares.