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
TheStreet Open House

FDA Provides Recommendations For Phase 2 Protocol For Low Dose Oral Proellex(R) In The Treatment Of Endometriosis

Stocks in this article: RPRX

THE WOODLANDS, Texas, Aug. 27, 2012 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc. ® (Nasdaq:RPRX) today announced the FDA has provided guidance for a Phase 2 study of low dose oral Proellex ® in the treatment of endometriosis. The following are the key elements of the guidance:

  • Trial patient population includes women diagnosed within the last 5 years via laparoscopic or other surgical techniques and as having severe endometriosis requiring narcotic analgesics.
  • The primary endpoint is percent reduction in narcotic usage to control endometriosis related pelvic pain from baseline to the end of the four month study comparing placebo to Proellex.
  • Other endpoints include reduction in individual elements of endometriosis related pain and overall analgesic usage.

Repros plans to submit the revised protocol to the FDA as soon as practicable. Once received, the FDA agreed to review the design within 30 days, at which time, if the protocol is acceptable, Repros could commence the Phase 2 trial in the fourth quarter of this year. The Company intends to enroll up to 90 women into the study (30 per arm).

The Company believes prior experience with higher dose Proellex bodes well for the eventual outcome of the trial. In previous studies of oral Proellex in women with severe endometriosis at doses of 25 and 50 mg, Proellex in comparison to placebo statistically significantly reduced the three elements of endometriosis related pain. The three elements of pain are dysmenorrhea or painful menses, dyspareunia or painful sex and non menstrual pelvic pain. In addition to the statistically significant reduction (p < 0.05) in all three pain elements, there was also a statistically significant reduction in the need for over the counter or narcotic analgesics used to control the endometriosis related pain in the Proellex arm.

Notably, there was no difference in the response between the two active doses. The Company believes the primary driver in pain relief associated with the use of Proellex is the suppression of menses. Both the 25 and 50 mg dose of Proellex suppress menses to the same extent.  Importantly, the two doses in the proposed Phase 2 study, 6 and 12 mg, have been shown to suppress menses equivalent to the two higher doses.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link 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

Jim Cramer's protégé, David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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!

Markets

DOW 17,451.72 +64.51 0.37%
S&P 500 2,031.47 +1.92 0.09%
NASDAQ 4,697.9180 +16.4210 0.35%

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