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FDA Reclassifies Proellex(R) Clinical Hold Status: Repros To Proceed With Phase 2 Study Of Low Dose Oral Proellex(R) In The Treatment Of Endometriosis

THE WOODLANDS, Texas, Oct. 8, 2012 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced the FDA has agreed to a reclassification of the full clinical hold on further oral Proellex® studies to a partial clinical hold to allow the Company to conduct a Phase 2 study of low dose oral Proellex® in the treatment of endometriosis. The Company believes the data generated from the study should allow the remaining partial clinical hold to be removed. The following points are the key elements of the 4 month trial:
  • Subjects previously diagnosed within the last 5 years via laparoscopic or other surgical technique as having endometriosis;
  • Subjects diagnosed with severe endometriosis and require narcotic analgesics to treat their endometriosis related pain;
  • The primary endpoint is the percent reduction in need for narcotic analgesics from baseline to the end of study comparing placebo to Proellex®;
  • Secondary endpoints will include electronic diary captured assessments of menstrual, non menstrual and intercourse related pain recorded using a validated instrument; and
  • The study will have three arms of 30 subjects each receiving placebo, 6 and 12mg Proellex®.

In previous studies in women with severe endometriosis at oral doses of 25 and 50 mg, Proellex®, in comparison to placebo, reduced the need for narcotic and non-narcotic analgesics to control the three elements of endometriosis related pain in a statistically significant and clinically relevant manner. The three elements of pain, dysmenorrhea or painful menses, dyspareunia or painful sex and non menstrual pelvic pain also achieved statistically significant reductions (p<0.05). Pain assessments were made using electronic diaries and a modified symptom survey recommended by the FDA.

Interestingly, there was no difference in the response between the two active doses. The Company believes this can be rationalized if 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 at the same rate. 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.

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