Antares Pharma Says FDA Approves OTREXUP Injection for Adults with RA
Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of OTREXUP^™ (methotrexate) injection by the U.S. Food and Drug Administration (FDA). OTREXUP^™ is the first FDA approved subcutaneous (SC) methotrexate (MTX) for once weekly self-administration with an easy-to-use, single dose, disposable auto injector. OTREXUP^™ is indicated for adults with severe active rheumatoid arthritis (RA) who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs), or children with active polyarticular juvenile idiopathic arthritis (pJIA). The FDA also approved adult use of OTREXUP^™ for symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy.
In 2012, approximately six million prescriptions were written across all dosage forms of MTX in the U.S. to treat patients for RA, pJIA and psoriasis, the same indications for which OTREXUP^™ has been approved. MTX treatment is usually initiated with oral tablets, however; many patients experience an inadequate response for reasons of efficacy or tolerability.
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