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Repros Says FDA Needs Proellex Safety Analysis

From Associated Press (May 29, 2012)

THE WOODLANDS, Texas -- Repros Therapeutics Inc. said Tuesday it will have to run a safety analysis of its drug Proellex before it can resume human testing.

Repros is trying to get approval for Proellex as a treatment for menstrual bleeding associated with uterine fibroids and for endometriosis. The oral version is intended to treat endometriosis, a condition in which a tissue similar to the uterine lining is found outside of the uterus, such as on the ovaries. It can cause pelvic pain and infertility. The uterine fibroids treatment is intended to be delivered vaginally.

The company said Tuesday that it will have to perform a safety analysis of its past clinical trials of oral Proellex and submit its findings to the Food and Drug Administration. The FDA will review the results within 30 days and may allow the company to continue studying low doses of Proellex. Development of the drug has been held up because of concerns about its effects on the liver of patients.

Repros said that by June it expects to finish enrolling patients in a study of Proellex-V, the uterine fibroid treatment. It expects to have results from that trial during the fourth quarter of 2012. It also intends to enroll patients from that trial into a safety study.

Shares of Repros Therapeutics fell 27 cents, or 3 percent, to $8.74 Tuesday. In after-hours trading the stock lost 42 cents, or 4.8 percent, to $8.32.


Posted: May 2012