Proellex telapristone regulatory update

Repros said FDA provided guidance for the company's clinical program for low-dose oral Proellex telapristone to treat uterine fibroids and endometriosis, while remaining on a partial clinical hold. The company plans to begin a 3-arm, double-blind Phase II trial of Proellex in fewer than 75 patients with uterine fibroids this year. The highest allowed dose will be 12 mg daily. Repros said it will comply with FDA guidance on the agency's preferred efficacy endpoint - reduction in excessive menstrual bleeding associated with uterine fibroids - and said the agency noted the preferred methodology to determine changes in bleeding. Repros will also collect additional efficacy outcomes, including tumor size and other symptomatic relief. Proellex is a selective progesterone receptor modulator (SPRM). ...