New Injection Device Approved for Methotrexate

A self-injection device for the subcutaneous administration of methotrexate (MTX) facilitates drug delivery for arthritis sufferers.

The Otrexup self-injector is intended for use by adults with active, severe rheumatoid arthritis (RA) or psoriasis who have not responded to or been able to tolerate first line therapy, as well as for children with active polyarticular juvenile idiopathic arthritis. The device is not indicated for use in children with psoriasis, nor should it be used by pregnant women. And while MTX is also used in the treatment of cancer, Otrexup is not indicated for that use.

Methotrexate is considered a disease-modifying antirheumatic drug (DMARD), effective in relieving joint inflammation and pain, slowing disease progression, and preventing disability by delaying joint destruction. People with RA may be more likely to continue treatment with MTX than with other DMARDs, with more than 50% of people who take MTX for RA continuing to take the medicine for more than three years, longer than any other DMARD. The Otrexup self-injector is a product of Antares Pharma (Ewing, NJ, USA), and has been approved by the US Food and Drug Administration (FDA).

“We are very pleased to receive approval from the FDA for Otrexup because we believe it is an important step up in the standard of care for people living with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and psoriasis,” said Paul Wotton, PhD, president and CEO of Antares Pharma.

“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 and therefore benefit from subcutaneous methotrexate,” commented Michael Schiff, MD, of the University of Colorado (Denver, USA).

MTX is a cornerstone of therapy for RA and psoriasis, usually given orally once a week, but a substantial number of patients do not respond adequately or cannot tolerate the side effects of the drug, such as nausea, abdominal pain, and dyspepsia. Those patients can be given methotrexate with subcutaneous injections, which can increase the drug's bioavailability, but injection can also pose problems for patients who are afraid of needles or do not have enough manual dexterity remaining to manage needles, syringes, and vials.

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