Antares Pharma's patented VIBEX™ auto-injection system is being developed to treat patients suffering from rheumatoid arthritis (RA) and several other autoimmune diseases. Otrexup™ (methotrexate injection) offer rapid subcutaneous (SC) self-administration of methotrexate (MTX) in three simple steps.
As a promising pre-biologic treatment, it is anticipated that Otrexup™ could play an important role in lowering healthcare costs in RA by delaying the use of biologic agents and expanding the use of MTX. The availability of Otrexup™ would give patients and physicians a new option before making the jump to expensive biologics, which are associated with serious and increased safety risks for RA patients.
Successful Study Results In a clinical pharmacokinetic study Otrexup™ successfully met its primary endpoints with results demonstrating that Otrexup™ provided equivalent pharmacokinetic performance with safety comparable to subcutaneous or intramuscular MTX injection using a conventional needle and syringe. The study evaluated several dose strengths in a range of 10mg to 25mg of Otrexup™ administered by a healthcare professional to RA patients.
The filing of a new patent application based on findings from the study will potentially fortify our patent portfolio around the VIBEX™ auto injector system. The VIBEX™ auto injector system is already protected by several issued and pending patents.
Rheumatoid Arthritis RA is a chronic, debilitating disease that causes pain, stiffness, swelling, and loss of joint function. Inflammation is caused by the immune system attacking healthy tissue and joints become progressively less mobile or even permanently damaged. The disease occurs in 0.5 to 1.0 percent of the world's adult population, affecting women at twice to three times the rate as that in men. According to the Centers for Disease Control and Prevention(CDC) website, RA affected an estimated 1.5 million adults in the U.S. in 2007.
Methotrexate Used in an estimated 70% of patients alone and in combination with biological therapies, MTX is a foundational disease-modifying anti-rheumatic drug (DMARD) for RA. Generally initiated orally at lower doses and titrated up, published studies have reported as many as 30% to 60% of patients experience gastrointestinal side effects with oral MTX. This can prevent further dose escalation or require discontinuation in some patients. In addition, the extent of oral absorption of MTX varies considerably between patients and has been shown to decline with increasing doses.