Repros Therapeutics announced it held a meeting with the US Food and Drug Administration to discuss oral Proellex in the treatment of uterine fibroids.
Repros Therapeutics (NASDAQ:RPRX) announced it held a meeting with the US Food and Drug Administration to discuss oral Proellex in the treatment of uterine fibroids.
As quoted in the press release:
Shortly before the meeting, the Company was notified that the meeting would be a type C/Guidance meeting, rather than a type B/End of phase 2 meeting as previously anticipated. At the meeting, the FDA confirmed that Proellex® will continue on the current partial clinical hold while they consult with liver experts within the FDA regarding previously disclosed effects on the liver. Further, the FDA agreed to accept additional information from the Company and its panel of liver experts for consideration by the FDA’s internal advisory liver team. The Company expects to submit the additional information and a proposed clinical protocol within a month. The Company intends to announce further information following receipt of additional guidance from the FDA.
Larry Dillaha, M.D., the Company’s President and Chief Executive Officer, commented, “The Company is pleased with the guidance received from the FDA, and while we remain on the current partial clinical hold as the FDA internally reviews our data related to the effect of Proellex® on the liver, we will proceed with our development plans by submitting additional phase 2 protocols to the FDA for their review. We are committed to working closely with the FDA as we further our development program for Proellex®.”
About Repros Therapeutics Inc.®
Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.