FDA Reclassifies Clinical Hold on Repros’ Mid-Stage Endometriosis Trial

The FDA reclassified its clinical hold on Repros Therapeutics’ Proellex and will now allow the company to conduct a Phase II trial of low-dose Proellex as a treatment for endometriosis. The four-month study, which is on a partial clinical hold, will compare the reduction in need for narcotic analgesics in 90 women with severe endometriosis who are taking placebo, 6 mg or 12 mg Proellex (telapristone). Secondary endpoints of the trial will assess menstrual, nonmenstrual and intercourse-related pain.
Washington Drug Letter