FDA Gives Repros the Go-Ahead for Low-Dose Proellex Study

The FDA has allowed Repros Therapeutics to run a single, low-dose study of its uterine fibroid and endometriosis drug Proellex under a partial clinical hold. In the new study, escalating doses (1, 3, 6, 9 and 12 mg) of the drug will be compared with placebo. No higher doses will be studied until Repros is confident that it is safe to proceed to the next dose and has reported safety findings to the FDA, the company said. Repros expects to enroll 60 subjects in the low-dose study. The move follows a request by Repros in April to lift the full clinical hold placed by the FDA last year.
Clinical Trials Advisor