FDA Recommends Running Phase 2b Trial of Proellex-V in the Treatment of Severe Menstrual Bleeding Associated With Uterine Fibroids


THE WOODLANDS, Texas, May 22, 2013 (GLOBE NEWSWIRE) — Repros Therapeutics Inc.(R) (Nasdaq:RPRX) today announced it has met with the FDA regarding the clinical development of Proellex-V, the vaginally administered product, in the of . The FDA recommended that a 2b study should be conducted as a prelude to the 3 program. During the meeting, Repros and the FDA agreed that:

  —  The primary indication and label for Proellex-V should be treatment of
      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 clinical and non-clinical program. The Company feels that many requirements have already been satisfied by completed studies using oral Proellex. The FDA acknowledged they would consider the information presented in white papers that Repros will prepare and cross-referenced submissions. The Company believes the completed studies with oral Proellex provide a very large margin of safety for the Proellex-V program.

Professor Alfred Poindexter, MD, Department of OB/GYN, Baylor College of Medicine, noted, “The early experience generated at my clinical site with vaginally administered telapristone suggests…Read more

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