The US Food and Drug Administration (FDA) has approved Antares Pharma's (Antares) OTREXUP, a single-dose, disposable auto-injector for the subcutaneous (SC) once-weekly administration of methotrexate (MTX).
OTREXUP is reportedly the first proprietary product featuring the VIBEX Medi-Jet technology, intended to treat adults with rheumatoid arthritis (RA) and psoriasis as well as children with polyarticular juvenile idiopathic arthritis (pJIA).
The drug is given to adult patients with severe active 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).
Usually MTX treatment is given orally once a week, but many patients experience an inadequate response for reasons of efficacy or tolerability.
The FDA approval is based on study data that showed 'increased bioavailability' of SC MTX compared with oral MTX at various doses.
The company said that, the results confirm and strengthen the findings of previously published bioavailability data, and underline the saturable limitations of oral MTX that result in a bioavailability plateau of 15mg.
Antares Pharma president and CEO Paul Wotton said the FDA approval for OTREXUP is an important step up in the standard of care for people living with RA, pJIA and psoriasis.
"This approval represents a strategic milestone for Antares because we believe it validates our proprietary VIBEX Medi-Jet technology which provides a significant advance in improving health outcomes with high tech but easy self-administration of SC medications," Wotton said.
"Our VIBEX proprietary technology is protected by numerous granted patents and OTREXUP is protected by several patents through at least 2030."
