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Repros Therapeutics Inc. (RPRX) to Submit IND for Vaginal Delivery of Proellex(R) for Fibroid De-bulking and Symptom Elimination


9/9/2011 10:08:41 AM

THE WOODLANDS, Texas, Sept. 8, 2011 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced it will submit an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for the use of vaginally delivered Proellex for significant fibroid size reduction and symptom elimination with the goal of avoiding surgery. This announcement follows a pre-IND teleconference with the FDA regarding the elements that the Company plans to include in the IND along with the initial Phase II study in women with uterine fibroids. The FDA noted that no new preclinical studies are required to begin human trials. Importantly, the FDA also indicated that the vaginal formulation will not be subject to the partial clinical hold that the oral IND is on currently

Read at GlobeNewswire

   

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