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.
Joseph S. Podolski, President and CEO of Repros, commented, "We are pleased with the FDA's willingness to consider continued development of low dose oral Proellex. We believe Proellex will offer distinct advantages over approved therapies as well as those currently under development, for this significant and undertreated female health disorder."It is estimated that nearly 5 million women of reproductive age in the US and Canada suffer from endometriosis. The disorder is characterized by severe pelvic abdominal pain that, in many cases, peaks during menses. In severe cases hysterectomies are the intervention of last resort. About Repros Therapeutics Inc. Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders. Any statements made by the Company that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including the ability to raise additional needed capital on a timely basis in order for it to continue to fund development of its Androxal® and Proellex® programs, have success in the clinical development of its technologies, the reliability of interim results to predict final study outcomes, and such other risks which are identified in the Company's most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov . Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For more information, please visit the Company's website at http://www.reprosrx.com. The Repros Therapeutics Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7738
CONTACT: Repros Therapeutics Inc. Joseph Podolski (281) 719-3447 President and Chief Executive Officer Investor Relations: Thomas Hoffmann The Trout Group (646) 378-2931