Yesterday, Antares Pharma announced positive results from its actual human use (AHU) study of VIBEX Methotrexate (MTX). The multicenter, open-label, single-arm, in-clinic study was conducted to evaluate the actual human use of MTX when administered through the VIBEX Medi-Jet in adult patients suffering with rheumatoid arthritis (RA).
The study’s primary objective was assessing the safe usability of VIBEX MTX for self-administration parenteral MTX in adult RA patients, following standardized training by site personnel and patient review of written directions. The study’s secondary objectives included evaluating the reliability, user-friendliness, and robustness of the VIBEX Medi-Jet; determining the safety and local tolerance of Medi-Jet-administered MTX; and gauging the effectiveness of patient education tools, including written instructions.
The AHU study included three visits over a nine-day period, as well as a screening period, a treatment period and a follow-up visit. In all, 101 patients were enrolled in four study dose groups: 10 mg. (n=20), 15 mg. (n=30), 20 mg. (n=31) and 25 mg. (n=20). Patients self-administered the single MTX dose using the VIBEX Medi-Jet.
The study’s results show that self-administration of MTX using the VIBEX Medi-Jet is safe and well-tolerated. After receiving standardized training from site personnel and reviewing written instructions, all 101 patients were able to successfully perform the self-administration. Additionally, the VIBEX Medi-Jet functioned properly and as intended for all administrations – showing dependability and robustness. As indicated on the “Ease of Use” questionnaire, 98 percent of patients found the VIBEX Medi-Jet to be easy to use, and all patients found the instructions and training clear and simple to follow. At the conclusion of the treatment period, patients were asked about site administration pain, which was measured using a 100 mm visual analog scale (VAS). The results showed that patients experienced minimal or no pain, with a mean value of 3.6 mm on a scale of 100 mm. Most importantly, no treatment-emergent serious adverse events related to the drug were experienced by patients.
The study demonstrated that RU patients can successfully self-administer MTX with the VIBEX Medi-Jet, and the study’s findings keep Antares Pharma on track to file a New Drug Application for VIBEX MTX in early 2013.
Focused on self-administered parenteral pharmaceutical products and topical gel-based medicines, Antares Pharma has technology platforms that include VIBEX disposable Medi-Jet, disposable multiuse pen injectors, and Vision reusable needle-free injectors marketed as Tjet and Zomajet. Antares Pharma has product marketing agreements with various companies, including Teva Pharmaceutical Industries Ltd., Ferring Pharmaceuticals, Watson Pharmaceuticals, and Jazz Pharmaceuticals. Antares Pharma operates two U.S. facilities: Parenteral Products Group in Minneapolis, Minn., and Product Development Group and corporate offices in Ewing, N.J.
For more information, visit the company’s Web site at www.antarespharma.com
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