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www.fdanews.com/articles/126465-repros-asks-fda-to-lift-hold-plans-safety-study-for-proellex

Repros Asks FDA to Lift Hold, Plans Safety Study for Proellex

April 23, 2010
Repros Therapeutics has requested that the FDA lift a full clinical hold on Proellex, its uterine fibroids and endometriosis drug candidate. The company is asking the agency to allow it to conduct a short-term safety study to identify the minimum effective dose of Proellex to induce amenorrhea, an absence of periods, Repros CEO Joseph Podolski said. The FDA placed the hold last year after 13 patients had clinically significant increases in liver enzymes, seven of which were considered serious adverse events and reported to the agency. The company voluntarily suspended dosing of patients prior to the hold.
Clinical Trials Advisor