Repros Therapeutics says FDA gave guidance for Phase 2 study Repros Therapeutics announced the FDA has provided guidance for a Phase 2 study of low dose oral Proellex in the treatment of endometriosis. The following are the key elements of the guidance: Trial patient population includes women diagnosed within the last 5 years via laparoscopic or other surgical techniques and as having severe endometriosis requiring narcotic analgesics. The primary endpoint is percent reduction in narcotic usage to control endometriosis related pelvic pain from baseline to the end of the four month study comparing placebo to Proellex. Other endpoints include reduction in individual elements of endometriosis related pain and overall analgesic usage. Repros plans to submit the revised protocol to the FDA as soon as practicable. Once received, the FDA agreed to review the design within 30 days, at which time, if the protocol is acceptable, Repros could commence the Phase 2 trial in the fourth quarter of this year. The company intends to enroll up to 90 women into the study. The Company believes prior experience with higher dose Proellex bodes well for the eventual outcome of the trial.
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Repros needed unique Androxal label even before ADCOM panel, says Ladenburg Ladenburg said that given the FDA advisory committee's 20 to 1 vote that it believes the FDA will likely revise testosterone replacement therapy labels to restrict their use in hypogonadal patients with clear etiology. However, Ladenburg added that Repros was always going to have to establish a unique label for Androxal and the firm believes that the company's ongoing and completed trials will provide sufficient data for filing and approval by the FDA in secondary hypogonadism. The firm maintains its Buy rating and $35 price target on Repros.
Repros Therapeutics sell-off overdone, says Brean Capital Brean Capital said the selling in Repros Therapeutics is overdone after an FDA panel voted overwhelmingly in support for a more restrictive label that limits the use of TRT drugs to only patients with classic hypogonadism. The firm feels since Androxal has not been targeting age-related hypogonadism it does not deserve to be negatively impacted by yesterday's ruling. Brean Capital maintains its Buy rating on Repros Therapeutics and $41 price target on the shares.