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December 17, 2012
09:02 EDTATRSAntares Pharma submits NDA for OTREXUP to FDA
Antares Pharma announced the submission of a NDA to the FDA for OTREXUP, a combination product for the delivery of methotrexate using Medi-Jet™ technology. OTREXUP was developed for easy subcutaneous administration of MTX to enhance the treatment of rheumatoid arthritis, poly-articular-course juvenile RA and moderate to severe psoriasis. The NDA submission, subject to acceptance and approval by the FDA, was supported by data generated from a clinical development program completed in accordance with the FDA’s guidance and recommendations. Antares executed and completed all of the clinical studies agreed with the agency and described in the clinical development program.
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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.
April 16, 2014
07:03 EDTATRSAntares Pharma announces additional patent coverage for OTREXUP
Antares Pharma announced the issuance of U.S. Patents RE44846 and RE44847. These patents are reissued versions of U.S. Patents 7,744,582, and 7,776,015. These patents add protection to OTREXUP as well as Antares’ pipeline products. Antares is taking steps to supplement the current Orange Book listings related to OTREXUP.

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