Antares Pharma announced that the U.S. Food and Drug Administration has accepted the New Drug Application (NDA) for OTREXUP, a potential new product for subcutaneous delivery of methotrexate (MTX) using the company’s Medi-Jet technology. OTREXUP is currently being developed for MTX self-administration to enhance the treatment of rheumatoid arthritis, poly-articular-course juvenile RA, and psoriasis.
A Prescription Drug User Fee Act (PDUFA) date of Oct. 14 has been assigned by the FDA, which is 10 months from the official NDA filing, so that is the target date for the FDA to complete its NDA review of OTREXUP.
Obtaining FDA acceptance of OTREXUP marks an important start to the review process, as well as a significant milestone for Antares Pharma’s shareholders.
“We look forward to working closely with the FDA during their review of the application,” said Antares Pharma President and CEO Paul K. Wotton, Ph.D.
A proprietary parenteral drug delivery system protected by several issued and pending patents, Medi-Jet is a trademark of Antares Pharma. Medi-Jet is designed to make it quick and easy for patients to subcutaneously or intramuscularly self-administer a drug – also enhancing safety with an integrated, shielded needle to protect against accidental needle stick and drug exposure.
Used in a majority of patients, either on its own or combined with biological therapies, methotrexate is a commonly prescribed disease-modifying anti-rheumatic drug (DMARD).
For more information, visit www.antarespharma.com
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