Repros Therapeutics has received guidance from the FDA regarding its clinical program for low dose oral Proellex in the treatment of uterine fibroids. Repros 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 II
• 112,576: vaginal treatment for fibroids – STATUS: Initiating Phase IIb

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).

At the meeting, the FDA provided guidance to Repros for acceptable endpoints for the treatment of uterine fibroids. The agency instructed the company to submit a request for lifting of the full clinical hold at the same time it submits a new protocol. Repros plans to follow the FDA’s recommendations and submit the protocol and full hold lift in a timely fashion.

Repros will use the same design for the vaginal Phase IIb study and expects to start the two studies in early 2014.