Antares Pharma (ATRS) Updates on AHU for VIBEX MTX; Says Self-Admin Was Safe
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Antares Pharma, Inc. (Nasdaq: ATRS) shares are higher in early trading following an update on its AHU study for VIBEX MTX. The full release is below:
[Antares Pharma] announced positive results from an Actual Human Use (AHU) study for VIBEX Methotrexate (MTX). The clinical trial was conducted as a multi-center, open-label, single-arm, in-clinic study to evaluate the actual human use of methotrexate administered via the VIBEX Medi-Jet in adult patients with rheumatoid arthritis (RA).
The study assessed the safe usability of VIBEX MTX for self-administration of parenteral MTX in adult RA patients after standardized training by site personnel and review of written instructions. Secondary objectives included evaluation of the reliability, ease of use and robustness of the VIBEX Medi-Jet; assess the safety and local tolerance of Medi-Jet administered MTX and to evaluate the effectiveness of the patient education tools including written instructions for use.
The Actual Human Use study consisted of three visits over nine days and included a screening period, a treatment period and a follow-up visit. In total, 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). The single MTX dose was self-administered by the patient from one of the four dose groups using the VIBEX Medi-Jet.
The results of this study show that self-administration of MTX using the VIBEX Medi-Jet is safe and well tolerated. Following standardized training by site personnel and review of written instructions, all 101 patients performed the self-administration successfully. In addition, the VIBEX Medi-Jet functioned correctly and as intended for each and every administration thereby demonstrating reliability and robustness. Results of the Ease of Use Questionnaire indicated that 98% of patients found the VIBEX Medi-Jet easy to use and 100% of patients found the instructions and training to be clear and easy to follow. Patients were also asked to report site administration pain at the end of the treatment period. Administration site pain was measured using a 100 mm Visual Analog Scale (VAS) and showed that patients experienced minimal or no pain with a mean value of 3.6 mm on a scale of 100 mm. Importantly, no patients experienced treatment-emergent serious adverse events related to the drug.
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[Antares Pharma] announced positive results from an Actual Human Use (AHU) study for VIBEX Methotrexate (MTX). The clinical trial was conducted as a multi-center, open-label, single-arm, in-clinic study to evaluate the actual human use of methotrexate administered via the VIBEX Medi-Jet in adult patients with rheumatoid arthritis (RA).
The study assessed the safe usability of VIBEX MTX for self-administration of parenteral MTX in adult RA patients after standardized training by site personnel and review of written instructions. Secondary objectives included evaluation of the reliability, ease of use and robustness of the VIBEX Medi-Jet; assess the safety and local tolerance of Medi-Jet administered MTX and to evaluate the effectiveness of the patient education tools including written instructions for use.
The Actual Human Use study consisted of three visits over nine days and included a screening period, a treatment period and a follow-up visit. In total, 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). The single MTX dose was self-administered by the patient from one of the four dose groups using the VIBEX Medi-Jet.
The results of this study show that self-administration of MTX using the VIBEX Medi-Jet is safe and well tolerated. Following standardized training by site personnel and review of written instructions, all 101 patients performed the self-administration successfully. In addition, the VIBEX Medi-Jet functioned correctly and as intended for each and every administration thereby demonstrating reliability and robustness. Results of the Ease of Use Questionnaire indicated that 98% of patients found the VIBEX Medi-Jet easy to use and 100% of patients found the instructions and training to be clear and easy to follow. Patients were also asked to report site administration pain at the end of the treatment period. Administration site pain was measured using a 100 mm Visual Analog Scale (VAS) and showed that patients experienced minimal or no pain with a mean value of 3.6 mm on a scale of 100 mm. Importantly, no patients experienced treatment-emergent serious adverse events related to the drug.
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