Antares’s line of versatile mini-needle, needle-free pen injectors addresses an array of application requirements.

Patients’ demands for ever-increasing healthcare utilization are often at odds with payors’ desires to contain costs. Yet, there is one aspect of medicine where the two groups are aligned: where they want medicine delivered.

Insurers want treatment delivered in the most economical setting while patients want treatment delivered in the most convenient and comfortable setting. For both, that means shifting treatment delivery from hospitals and clinics to the convenience of home.

There are several factors driving this trend. Increased incidence of diseases such as diabetes and the availability of therapies for previously untreatable conditions are rapidly expanding the injectables market. The surge in biotech-based research means that many more protein therapeutics (which often require injection) are reaching the market. Additionally, the advanced features of modern-day self-injection devices are making them more acceptable to patients. If patients can self administer their medications, then not only is it more convenient for them, it also saves on healthcare resources and costs, making self injection much more cost effective.

Self-injection devices typically improve safety and efficacy, reduce side effects, and enhance absorption to achieve efficacy with a lower dose. Pens and auto-injectors address the patients’ needs for improved self-injection experience and the physicians’ needs for a therapeutic approach with which they are confident their patients will comply. This saves the healthcare system by facilitating a lower-cost way to administer medicines and improve therapeutic outcomes by enhanced compliance.

Antares Pharma, Inc, recently identified such an opportunity. We recognized the need for the Vibex injection system, which enables rheumatoid arthritis patients to self-administer methotrexate injections. Methotrexate, a frequently prescribed disease-modifying anti-rheumatic drug, is standard of care for about 70% of patients. It is generally administered orally, and although convenient, oral methotrexate has significant limitations. First, the oral dose is variably absorbed. The mechanism by which methotrexate is absorbed can become saturated as the dose is increased. As a result some patients are unable to absorb enough of the drug to get an efficacious response. Second, oral methotrexate is associated with a high incidence of dose-related gastrointestinal side effects, which further interferes with titrating patients to a sufficient dose to get an efficacious response. This side effect may cause patients to skip or stop taking the medication on a regular schedule.

Giving methotrexate by injection helps to overcome both of these problems. First, methotrexate by injection is consistently absorbed and does not rely on the mechanism required for oral absorption. As a result, more patients can be titrated to a sufficiently high enough dose to get an effective response. Second, methotrexate by injection is associated with a lower incidence of gastrointestinal side effects, presumably because there is less direct exposure to the GI tract than with oral dosing. Both of these benefits can help more patients tolerate and achieve better therapeutic efficacy with methotrexate.

So why do less than 1 in 10 RA patients receive methotrexate by injection? Simply put—it’s too impractical to be the routine. Patients would need to visit their physician’s office weekly for the injection. Or, they would need to learn to prepare the injection from vials and the technique for administering intramuscular injections. Since methotrexate is a cytotoxic agent, there is also the concern on inadvertent exposure and inappropriate disposal. Either approach is sufficiently burdensome to discourage the use of injection methotrexate for most patients. Instead, patients are escalated to expensive biological agents at a cost typically exceeding $15,000 per year. Although these agents are injectable as well, they are configured in easyto- use auto-injection systems that simplify the selfinjection process for patients.

Real need

When patients feel that it’s inconvenient, unpleasant, and costly to go to a doctor’s office for weekly treatment, this sometimes results in patients who don’t see doctors very often, don’t get the follow-up they need, and can’t get prescriptions refilled because a physician hasn’t examined them in months. At-home medical care, including self injections, may be the only kind of medical care they’ll regularly receive.