Antares Pharma Inc (ATRS) Tuesday announced positive results from a human factors usability study for VIBEX Methotrexate, a proprietary auto injector product designed to self-administer a rapid subcutaneous weekly injection of methotrexate for the treatment of rheumatoid arthritis, or RA.
The company, focused on self-injection pharmaceutical products and topical gel-based medi8cines, stated that the purpose of this usability study was to conduct a cumulative and summative round of simulated usability testing of the VIBEX MTX device in accordance with Food and Drug Administration draft guidance "Applying Human Factors and Usability Engineering to Optimize Medical Device Design, dated June 22, 2011".
The company further stated that the study design was reviewed by the FDA prior to initiation.
Antares Pharma further revealed that the results of the study showed that the VIBEX MTX device is safe and effective for intended users, uses and use environments. The validation testing proved the product is easy to learn and safe to use as demonstrated by correct and successful injections.
"We are very encouraged by the results of the usability study, particularly in the rheumatoid arthritis patient group where the intended users of our VIBEX MTX device will have moderate to severe hand function impairment," said Kaushik J. Dave R.Ph., Ph.D., and Executive Vice President Product Development.
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