Repros Allowed To Conduct Phase 1, 2 Studies Of Oral Proellex - Quick Facts

(RTTNews) - Repros Therapeutics Inc.(RPRX) Monday said it has received guidance from the FDA indicating that the company may proceed to conduct Phase 1 and 2 studies of oral Proellex under two separate INDs for endometriosis and uterine fibroids, while remaining on partial clinical hold.

The FDA guidance provides that the highest allowed dose will be 12 mg daily. Repros is currently conducting a Phase 2 study for the use of Proellex in severe endometriosis and plans to submit a Phase 2 protocol for the treatment of symptomatic fibroids.

Regarding the proposed uterine fibroid Phase 2 protocol, the FDA provided guidance as to the appropriate inclusion and exclusion criteria for study subjects as well as the preferred efficacy endpoint. The FDA preferred efficacy endpoint is reduction in excessive menstrual bleeding associated with uterine fibroids.