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Repros Therapeutics Inc Announces That FDA Recommends Running Phase 2b Trial Of Proellex-V In Treatment of Severe Menstrual Bleeding Associated With Uterine Fibroids

Wednesday, 22 May 2013 08:00pm EDT 

Repros Therapeutics Inc 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 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. 

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