Repros Therapeutics has an end of phase II meeting scheduled with FDA in September, to discuss a phase III program investigating the use of Proellex in the treatment of endometriosis.
The phase II study demonstrated clinically and statistically significant reductions of the three key pain symptoms, commonly experienced by women with endometriosis-dysmenorrhea, non-menstrual pelvic pain and dyspareunia.
Additionally, the reduction of pain was accompanied by a significant reduction in the number of patients requiring pain medication in both doses in this study, compared with placebo. The study showed no efficacy differences between the 25mg and 50mg doses.
At the end of phase II study, Repros anticipates obtaining direction from FDA on the objectives and endpoints used in the pivotal phase III efficacy and safety studies in endometriosis.
Furthermore, Repros has decided to discontinue the use of the higher, 50mg dose in its ongoing studies in women with chronic symptomatic uterine fibroids and anemia.
The company said that earlier studies have demonstrated highly effective control of excessive menstrual bleeding and clinically significant improvement, at the lower doses of 12.5mg and 25mg.