Antares Pharma has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Otrexup, a combination product to deliver methotrexate methotrexate (MTX) using Medi-Jet technology.
Antares Pharma president and chief executive officer Paul Wotton said Otrexup is the first product designed for convenient subcutaneous delivery of MTX in patients with rheumatoid arthritis (RA) and 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," Wotton added.
Otrexup is also developed to optimize the clinical benefit of MTX, minimising the treatment costs.
The studies have also demonstrated safe, easy and comfortable use of Otrexup for RA patients to self-administer subcutaneous doses of MTX in comparison to oral doses.
Antares Pharma product development executive vice president Kaushik Dave said, "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."
Methotrexate is a disease-modifying anti-rheumatic drug, used in an estimated 70% of rheumatoid arthritis patients either on its own or in combination with biological therapies.
