THE WOODLANDS, Texas, May 22, 2013 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc. ® (Nasdaq:RPRX) today announced it has met with the FDA regarding the clinical development of Proellex-V, the vaginally administered product, in the treatment of uterine fibroids. The FDA recommended that a Phase 2b study should be conducted as a prelude to the Phase 3 program. During the meeting, Repros and the FDA agreed that:
- The primary indication and label for Proellex-V should be treatment of severe menstrual bleeding associated with uterine fibroids. To this end, the Pictorial Blood Loss Assessment (PBAC) was identified as the key primary endpoint;
- If the Company proposes a label that includes a claim based on patient reported outcome (PRO), such as bulk symptoms or quality of life, the PRO must be validated before the start of Phase 3; and
- The FDA will review the protocol prior to study initiation.