Antares Pharma, Inc. (NASDAQ: ATRS) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for OTREXUP™, a combination product for the delivery of methotrexate (MTX) using Medi-Jet™ technology. OTREXUP was developed for easy subcutaneous administration of MTX to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and moderate to severe psoriasis.
“The NDA submission of OTREXUP represents yet another significant accomplishment in the Company’s history,” said Paul K. Wotton Ph.D., President and Chief Executive Officer. “It is the first product designed for convenient subcutaneous delivery of methotrexate in patients with rheumatoid arthritis or psoriasis. We believe OTREXUP will benefit most patients that have not reached a satisfactory response to oral methotrexate alone or in combination with a biologic or another disease-modifying anti-rheumatic drug.”
OTREXUP was developed to optimize the clinical benefit of MTX, leading to cost effective treatment outcomes. Historically, parenteral MTX use has been limited in clinical practice for several reasons including the inconvenience of weekly intramuscular injections by a healthcare professional, and/or the challenges associated with teaching patients with impaired hand function, safe and sterile self-injection techniques. Studies conducted to date indicate OTREXUP is safe, easy and comfortable for RA patients to self-administer precise subcutaneous doses of MTX with improved systemic availability compared to oral doses.
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.
“The dedicated efforts of the entire Antares team have allowed us to submit a New Drug Application to the FDA ahead of schedule,” said Kaushik J. Dave R.Ph., Ph.D., Executive Vice President Product Development. “The results from the clinical development program have shown that OTREXUP can provide greater systemic exposure to methotrexate compared to oral doses. We believe OTREXUP is easy to use and comfortable for RA patients with moderate to severe hand function impairment thereby enhancing self-administration and patient compliance.”