FDA Recommends Running Phase 2b Trial of Repros' Proellex-V

Repros Therapeutics

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. Repros believes one of the key benefits of Proellex-V is the relief of the bulk symptoms associated with uterine fibroids and that inclusion of such claims in the label will provide a significant marketing advantage. The study will start in the latter half of this year and results are expected in mid 2014. Additional discussions focused on the overall