Antares seeks US FDA nod for Otrexup in RA, psoriasis
This article was originally published in Scrip
Antares is seeking the US FDA's approval to market the firm's subcutaneously administered methotrexate product Otrexup as a treatment for rheumatoid arthritis (RA), poly-articular-course juvenile RA and moderate to severe psoriasis.
The product delivers methotrexate using the company's Medi-Jet technology, which has a shielded needle that is intended to protect against accidental needle stick and drug exposure.
Antares CEO Dr Paul Wotton said the investigational product is the first designed for convenient subcutaneous delivery of methotrexate in patients with RA or psoriasis.
The drug, he said, will benefit most patients who have not reached a satisfactory response to oral methotrexate alone or in combination with a biologic or another disease-modifying anti-rheumatic medicine.
Use of parenteral methotrexate has often been limited because of the inconvenience of weekly intramuscular injections delivered by a health care professional or the challenges associated with teaching patients with impaired hand function the safe and sterile self-injection techniques, Antares said.
But Otrexup, the firm said, was developed to optimize the clinical benefit of methotrexate, leading to cost effective treatment outcomes.
Shares of Ewing, New Jersey-based Antares closed at $3.80, a gain of 5 cents, or 1.2%.