The US Food and Drug Administration (FDA) has approved the first subcutaneous methotrexate (MTX; Otrexup, Antares Pharma) for once-weekly self-administration in a single-dose, disposable autoinjector, using the manufacturer's proprietary parenteral drug delivery technology, Vibex Medi-Jet.
Otrexup is indicated for adults with severe active rheumatoid arthritis (RA) who have not responded adequately to or cannot tolerate first-line therapy, or for children with active polyarticular juvenile idiopathic arthritis (pJIA).
The FDA also approved Otrexup for adults with symptomatic control of severe recalcitrant, disabling psoriasis that fails to respond adequately to other forms of therapy. The drug will be available in early 2014.
"This new delivery system for [MTX] provides a welcome option for physicians and their patients to continue effective use of [MTX]. Otrexup can be used when a response is inadequate or there are tolerability issues with oral [MTX], before adding or switching to costlier therapies," Michael Schiff, MD, clinical professor of medicine in the Division of Rheumatology, University of Colorado School of Medicine, Denver, said in a company news release. "The availability of an easy and safe way to administer subcutaneous [MTX] 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 [MTX]."
"Providers already use injectable [MTX] for a variety of diseases, mostly RA," Kevin Deane, MD, from the Division of Rheumatology, University of Colorado at Denver Health Sciences Center, Aurora, said in an email to Medscape Medical News.
"Injectable MTX to date has come in large vial, and [the] patient draws up medication and injects it, typically 2.5 mg of medication per 0.1 mL. Drawing up and administering this medication may be somewhat difficult for some patients to do, especially with arthritic conditions," Dr. Deane noted.
"Approved injectable MTX could be good thing if is allows for easier use, better data [with regard to] bioavailability and efficacy when compared to oral MTX, it has broad approval for relevant diseases beyond RA, and cost is not a barrier. Right now, injectable MTX is quite cheap (some say cheaper than oral). But with [an] 'approved' form, cost may go up," Dr. Deane said.
He wondered, "If drug cost is increased, would it make its use prohibited in non-RA conditions? For example, if [it is] very expensive, would insurance companies cover its use in nonapproved conditions like vasculitis or myositis?"
The company would not say what the exact price will be. "Analysts are predicting it will cost $500 to $600 monthly," Elaine Andrecovich, from public relations firm Makovsky in New York City and media contact for Antares, told Medscape Medical News in an email.
Data from 3 clinical studies of Otrexup will be presented later this month at the American College of Rheumatology Annual Meeting in San Diego, California, the company said.
Another potential benefit, Dr. Deane said, is a "stable supply now that [it is] approved. In past years, there have been shortages of injectable MTX." Conversely, he noted, providers "could lose access to other manufacturer's injectable MTX if they are unwilling to make it due to lack of approval. Practitioners may also be at risk if they prescribe the nonapproved form of injectable MTX."
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Cite this: FDA OKs Methotrexate Autoinjector (Otrexup) - Medscape - Oct 18, 2013.