Antares Pharma has reported positive results from the human factors usability study of its VIBEX Methotrexate (MTX) device.
The integrated, shielded needle and lock-out VIBEX MTX device prevents accidental needle-sticks after use and enables rheumatoid arthritis (RA) patients to self-inject MTX conveniently at home.
In accordance with the US Food and Drug Administration draft guidance of ‘Applying Human Factors and Usability Engineering to Optimize Medical Device Design, dated 22 June 2011’, Antares conducted a cumulative and summative round of simulated usability testing of the VIBEX MTX device.
The study’s participants included 17 RA patients, 16 lay caregivers and 17 healthcare professionals with hand function impairment.
To determine the extent of hand function impairment associated with RA, the patients were screened twice using the health assessment 20-item disability scale (HAQ) and patients with an average HAQ score of 2.0 to 2.5 were enrolled in the study.
The RA patients and lay caregivers completed simulated injections on two days spaced one week apart, while healthcare professionals participated in a single session where they used the device on a simulated patient.
The study results demonstrated that the VIBEX MTX device is safe and effective.
The company is planning to conduct an ongoing human use study of VIBEX MTX device in 100 RA patients and expects to complete enrolment in the study by the third quarter of 2012.
Antares Pharma product development executive vice president Kaushik J. Dave said: "We are looking forward to completing the next development milestone of our VIBEX MTX product in 2012, which is a human use study in rheumatoid arthritis patients."