This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Antares Pharma Announces Successful Results From VIBEX MTX Actual Human Use Study

Antares Pharma, Inc. (NASDAQ: ATRS) today 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.

“We believe that the successful completion of this study is important for Antares as we continue to build our company and further control our key product programs,” said Paul K Wotton, Ph.D., President and Chief Executive Officer. “The performance of the VIBEX Medi-Jet in this clinical study also validates our technology platform upon which we are developing multiple products like MTX and Testosterone, optimizing treatment options and allowing patients to self-administer parenteral medications conveniently at home and potentially reduce overall healthcare costs.”

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.

1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $93.11 -0.54%
FB $118.14 0.07%
GOOG $698.21 0.36%
TSLA $213.95 -3.90%
YHOO $37.17 3.30%


Chart of I:DJI
DOW 17,700.50 +49.24 0.28%
S&P 500 2,053.78 +2.66 0.13%
NASDAQ 4,725.5250 -0.1140 -0.00%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs