Repros Receives FDA Guidance for Proellex
Repros Therapeutics (NASDAQ: RPRX) today reported it has received guidance from the FDA regarding its clinical program for low dose oral Proellex in the treatment of uterine fibroids.
The Company currently has three open INDs for Proellex:
70,535 - oral treatment of fibroids STATUS: Full Clinical Hold
76,631 – oral treatment for endometriosis STATUS: Partial Clinical Hold and in Phase 2
112,576 – vaginal treatment for fibroids STATUS: Initiating Phase 2b
The Company held a meeting with the FDA on October 31, 2013 to discuss "going forward" plans for low dose oral Proellex in the treatment of uterine fibroids and to lift the clinical hold. In 2007, data had been discussed with the FDA based on the efficacy of a 12mg dose. The earlier study showed highly statistically significant results in achieving clinically relevant improvements in menstrual bleeding as well as symptoms associated with tumor bulk via a previously validated quality of life instrument (UFSQOL).
During the meeting with the FDA, the Agency provided guidance to the Company