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April 17, 2014
07:06 EDTATRSAntares Pharma says ARD publishes results from OTREXUP study
Antares Pharma announced that the Annals of the Rheumatic Diseases has published results from an open-label, head-to-head randomized, crossover study comparing the relative bioavailability, safety and tolerability of OTREXUP to oral methotrexate in adult patients with rheumatoid arthritis. In this multicenter, three-way crossover study, patients greater than or equal to 18 years old with adult RA undergoing treatment with MTX for three months or more were assigned to receive one of four dose levels of OTREXUP, 10 mg, 15 mg, 20 mg, and 25 mg weekly in a random sequence of three treatments: oral, subcutaneous into the abdomen and subcutaneous into the thigh. For 24 hours after the administration of each treatment, blood samples were collected to measure drug levels and injection sites were assessed. Forty-seven patients completed the study and the results showed that the systemic availability of methotrexate following oral dosing plateaus at 15 mg and greater. Following administration of OTREXUP, the systemic availability increased proportionally at every dose, which extended the range of exposure compared to patients receiving oral therapy. No unexpected adverse events were noted for either formulation in this short term study and higher systemic MTX exposure was not associated with increases in adverse events.
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September 15, 2014
07:01 EDTATRSAntares Pharma names Robert Apple as COO, effective immediately
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