- treat certain adults with severe, active rheumatoid arthritis (RA), and children with active polyarticular juvenile idiopathic arthritis (pJIA), after treatment with other medicines including non-steroidal anti-inflammatory (NSAIDS) have been used and did not work well.
- control the symptoms of severe, resistant, disabling psoriasis in adults when other types of treatment have been used and did not work well.
Antares Pharma, Inc. (NASDAQ: ATRS) today announced that data from a pivotal clinical trial of OTREXUP™ (methotrexate) for subcutaneous injection were selected for live, oral presentation during a clinical treatment strategies sub-session of the 2013 American College of Rheumatology (ACR) Annual Meeting, in San Diego. The abstract, entitled “Drug exposure limitations of oral methotrexate (MTX) at doses ≥15mg may be overcome by using a subcutaneous MTX auto-injector in patients with rheumatoid arthritis (RA),” was among a select group of key abstracts awarded the distinction of a live, oral presentation. In addition to the oral presentation, data from two other Antares-supported clinical studies were accepted for presentation at the ACR meeting as scientific posters. The clinical study data that will be presented live are from a randomized, open-label, three-way crossover study comparing the systemic availability of methotrexate using the OTREXUP™ self-administration device-drug combination compared with methotrexate taken orally. “We are pleased that the ACR included our pivotal OTREXUP™ data as an oral presentation at the premier rheumatology medical meeting in the United States,” said Paul K. Wotton, Ph.D., President and Chief Executive Officer. “We believe these data represent a significant step forward in addressing an unmet need in the current standard of care and may provide support for extending the use of methotrexate in rheumatoid arthritis patients.” The details for Antares’ oral presentation are as follows: Date & Time: Sunday, October 27 from 2:30-2:45 p.m. PT Location: Hall 6F Abstract Number: 796 Poster Title: Drug exposure limitations of oral methotrexate (MTX) at doses >15mgs may be overcome by using a subcutaneous MTX auto-injector in patients with rheumatoid arthritis (RA) Presenter: Michael H Schiff, M.D., University of Colorado, Denver The details for Antares’ poster presentations are as follows: Date & Time: Monday, October 28 from 9:00–11:00 a.m. PT Location: Poster Hall Abstract Number: 1337 Poster Title: Nearly pain free self-administration of methotrexate (MTX) using an investigational auto-injector: Results of a phase-2 clinical trial in rheumatoid arthritis (PA) patients with mild-to-severe functional limitations Presenter: Alan Kivitz, M.D., Altoona Center for Clinical Research, Duncansville, PA Date & Time: Tuesday, October 29 from 9:00-11:00 a.m. PT Location: Poster Hall Abstract Number: 2313 Poster Title: Pain-related anxiety as a barrier to use of subcutaneous (SC) methotrexate (MTX) in rheumatoid arthritis (RA): Comparing conventional vial, needles, and syringe (VNS) with an investigational auto-injector (AI) in healthy volunteers Presenter: Victoria Ruffing, RN, CCRN, Johns Hopkins Arthritis Center Johns Hopkins University, Baltimore, MD For full prescribing information please visit WWW.OTREXUP.COM IMPORTANT SAFETY INFORMATION OTREXUP ™ is a single-dose auto-injector containing a prescription medicine, methotrexate. Methotrexate is used to: