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FDA Approves Otrexup (Methotrexate) Injection for Arthritis and Psoriasis

Injection device designed for self-administration (October 14)

The FDA has approved Otrexup (methotrexate [MTX]) subcutaneous injection (Antares Pharma) for once-weekly self-administration with a 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 nonsteroidal anti-inflammatory drugs (NSAIDs), or for children with active polyarticular juvenile idiopathic arthritis (pJIA). The FDA also approved adult use of the product for symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy.

In 2012, approximately 6 million prescriptions were written across all dosage forms of MTX in the U.S. to treat patients with RA, pJIA, or psoriasis. MTX therapy 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 MTX compared with oral MTX at every dose. These results confirmed the findings of previously published bioavailability studies and highlighted a bioavailability plateau of 15 mg for oral MTX. These data are included in the approved label for Otrexup and will be presented this month at the American College of Rheumatology Scientific Meeting.

Source: Antares Pharma; October 14, 2013.

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