Repros To Try To License Stalled Drug Candidate
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RPRX
THE WOODLANDS, Texas (AP) Repros Therapeutics Inc. said Tuesday it will try to license its stalled drug candidate Propellex to another company after the Food and Drug Administration requested additional information on it.
The decision follows a meeting with the FDA in which the agency cast some doubt over whether the drug would be safe at any dosage. The agency also outlined steps the company needs to take in order to get the development program moving again. Propellex is being studied as a potential treatment to reduce the amount of menstrual bleeding associated with uterine fibroids, which are noncancerous growths of muscle fibers inside the uterus that can cause heavy menstrual bleeding, pelvic soreness and pain during sex. High doses of the drug candidate prompted elevated levels of liver enzymes in patients. Repros halted development of Propellex in August because of safety issues. That month, Repros said it was low on cash and couldn't cover expenses, and hired a law firm specializing in bankruptcy to focus on cutting debt. Since March, the company has said it would need to raise money to continue operating.- Loading Comments...
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