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FDA approves injectable methotrexate for RA, polyarticular JIA, psoriasis
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The FDA has approved a single-dose, disposable auto-injector containing methotrexate for treating patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis or psoriasis, according to Antares Pharma.
Otrexup is the first FDA-approved subcutaneous (SC) methotrexate (MTX) for self-administration once weekly, the company reported in a press release. It is indicated for adults with severe active rheumatoid arthritis who have experienced insufficient response or were unable to tolerate first-line therapy such as full-dose nonsteroidal anti-inflammatory drugs, or for children with active polyarticular juvenile idiopathic arthritis. It also has been approved for treating severe recalcitrant psoriasis.
The approval was based on study data that showed “increased bioavailability” of SC MTX compared with oral MTX at various doses.
“These results confirm and strengthen the findings of previously published bioavailability data, and highlight the saturable limitations of oral MTX that result in a bioavailability plateau of 15 mg,” Antares Pharma reported.
Common side effects of Otrexup included nausea, stomach pain, dyspepsia, mouth sores and rash. Possible serious side effects include organ system toxicity, pregnancy risks, non-Hodgkin’s lymphoma and tissue and bone problems, according to the release.
“This new delivery system for methotrexate provides a welcome option for physicians and their patients to continue effective use of methotrexate,” Michael Schiff, MD, clinical professor of medicine, rheumatology division, at the University of Colorado School of Medicine, Denver, said in the release. “Otrexup can be used when a response is inadequate or there are tolerability issues with oral methotrexate.
“The availability of an easy and safe way to administer subcutaneous methotrexate may overcome some of the current barriers to parenteral administration which could enable more patients to realize the possibility of continued disease control.”
Additional study data will be presented later this month at the American College of Rheumatology annual meeting in San Diego. Otrexup is expected to be commercially available in early 2014, Antares Pharma said.