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Repros Reports Positive Clinical Data for Vaginal Proellex® in Women With Severe Menstrual Bleeding Due to Uterine Fibroids

  • Primary endpoint of induction of amenorrhea met for both vaginal doses compared to placebo, p<0.0011
  • Proellex®-treated subjects reported a median 100% reduction in diary reports of menstrual bleeding product usage (PBAC)
  • Statistically significant reduction in fibroid size from baseline achieved for the combined active arms compared to increase in fibroid volume in placebo arm, p=0.0437
  • Low dose oral data from a comparable study to be reported in Q2 2016

THE WOODLANDS, Texas, April 12, 2016 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (RPRX) today reported that vaginal administration of Proellex® at doses of both 6 and 12 mg achieved significant reduction in excessive menstrual bleeding, the key symptom of uterine fibroids.

Normal menstrual blood loss in a menstrual cycle is approximately 35 mL. Woman experiencing blood loss of >80 mL are considered to suffer from menorrhagia or excessive menstrual bleeding. In this small Phase 2b study, 13, 15 and 14 women with confirmed uterine fibroids were enrolled in the 6mg, 12mg and placebo arms, respectively. At baseline, the mean amount of blood lost for one menstrual cycle was 255 mL, 274 mL and 238 mL for each arm, respectively. The blood loss ranged from a low of 94 mL to a high of 654 mL. The most severe menstrual bleeding at baseline was observed in the 12 mg group. Blood loss was determined by collecting all sanitary products used from an individual and then an alkaline hematin assay was performed to estimate the actual amount of blood collected in the pads.

When a sufficient concentration of Proellex® is achieved in circulation, amenorrhea (cessation of menses) is achieved. Just over half, 52%, of Proellex®-treated subjects became amenorrheic with no...