This Day On The Street
Continue to site right-arrow
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
TheStreet Open House

Repros Reports Preliminary Findings: Second Pivotal Study And 6-Month Safety Study Support Androxal(R) Approvability

Overall, the population entered this study with significant comorbidities. Approximately 20% had type 2 diabetes, 37% were diagnosed with hypertension and 70% had a BMI over 30. Approximately 79% had a significant risk factor for cardiovascular disease. Taking these facts into consideration, Androxal was generally well tolerated.

Also, with approximately 50% of subjects up-titrated to the higher dose, it is remarkable that there was no dose response noted in the incidence of adverse events. If anything, adverse events of note could have easily been attributed to raising of testosterone or just general age effects. For example 7.4% of subjects exhibited an elevation in PSA of 0.75 ng/ml or more. This is consistent with the experience reported for Androgel ®. As men were followed for two months after treatment, those men that experienced an increase in PSA generally returned to baseline levels as their T receded.

In the instance of DVT in Repros studies, Androgel ® has exhibited a higher frequency of increased hematocrit and hemoglobin than Androxal. Increased erythropoiesis directly affects an increased risk of developing a thromboembolic adverse event.

Several tables giving more in depth analysis of the safety profile determined from the study are available at the Company's website, .

Repros has exposed over 1,350 subjects to at least a single dose of Androxal. Almost 800 subjects have been exposed for at least 6 months of treatment. This represents over 90% of the safety database anticipated for the NDA filing.

Joseph Podolski, President and CEO noted, "We are encouraged by these outcomes. Our NDA filing remains on track for mid-2014. We believe we have the organization to successfully complete the required work and we have begun to prepare the necessary manufacturing documentation for the regulatory submission as well as having launch drug product available for an anticipated approval during 2015. The Company is in a strong financial position to maximize this unique Androxal opportunity."

4 of 5

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
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

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
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 17,712.66 +34.43 0.19%
S&P 500 2,061.02 +4.87 0.24%
NASDAQ 4,891.2190 +27.8570 0.57%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs