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August 27, 2012
16:13 EDTRPRXRepros Therapeutics says FDA gave guidance for Phase 2 study
Repros Therapeutics 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. The Company believes prior experience with higher dose Proellex bodes well for the eventual outcome of the trial.
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