FDA maintains clinical hold on Proellex (telapristone acetate), a treatment for uterine fibroids.- Repros Therapeutics

Repros Therapeutics Inc has announced that it received preliminary feedback from the FDA on the Company's clinical development program for Proellex, its oral delivery mechanism for telapristone acetate. The Proellex program will remain on partial clinical hold, and based upon the FDA's review of all the existing liver function safety data, the FDA has indicated that the Company will be required to compile a large pre-approval safety data base to support future development.

In light of the FDA guidance, the Company is assessing increasing its focus on its uterine fibroid and endometriosis development program utilizing a vaginal drug delivery program for telapristone acetate, a selective progesterone modulator (SPRM). Dr. Larry Dillaha, MD, Chief Executive Officer of Repros, commented, "We are encouraged by our clinical studies with our vaginal drug delivery program, which may provide the potential opportunity to differentiate our treatment from other orally-dosed compounds in development or on the market to treat uterine fibroids. Clinical work done to date suggests that vaginal delivery of telapristone acetate has the potential to yield good efficacy with significantly lower systemic blood levels. Furthermore, we intend to leverage drug delivery technology that could offer dosing less frequently than once per day."