This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
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

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

  • Androxal meets both co-primary endpoints in second pivotal study ZA-302
  • Testosterone normalized in 81% of patients
  • No deleterious effects on sperm function
  • No excursions above normal in 24 hour average testosterone
  • Androxal is generally well tolerated in 6 month safety study ZA-300
  • No dose dependent adverse events
  • Adverse event profile similar or superior to other approved testosterone therapies with over 90% of safety database collected
  • NDA submission on track

THE WOODLANDS, Texas, Sept. 16, 2013 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc. ® (Nasdaq:RPRX) today reported topline results from both the second pivotal efficacy study as well as the 6 month safety study of Androxal ® in the treatment of men with secondary hypogonadism. Secondary hypogonadism is the largest subset of hypogonadal men accounting for greater than 85% of the reported cases. Recent scientific publications, confirmed by Company experience, suggest obesity is the single greatest cause for hypogonadism. Subjects in all ongoing Androxal studies were required to exhibit morning testosterone (T) levels of <300 ng/dL on two separate consecutive mornings, be under 60 years of age and have a BMI over 25.

All men started at the lower 12.5 mg dose but up-titrated at any time during the study if their morning testosterone was < 450 ng/dL in the 6 month study and < 300 ng/dL in the efficacy study. The lower up-titration threshold was dictated by the FDA for the efficacy study. The Company believes a level of 450 ng/dL or higher will confer the desired clinical benefits of testosterone, including metabolic and quality of life improvements.

1 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
Only $9.95
14-Days Free
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!
SYM TRADE IT LAST %CHG

Markets

DOW 17,698.18 -77.94 -0.44%
S&P 500 2,059.69 -8.20 -0.40%
NASDAQ 4,880.2280 -20.6570 -0.42%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs