Repros Therapeutics Inc. announced that it has received guidance from the U.S. Food and Drug Administration (FDA) related to the development of oral Proellex for endometriosis and uterine fibroids.
The FDA has allowed Repros to conduct phase I and phase II studies on Proellex under two separate investigational new drug (IND) applications for endometriosis and uterine fibroids. However, the FDA maintained its partial clinical hold on Proellex.
Proellex is being developed for severe endometriosis – a phase II study is ongoing. The company is planning to submit the protocol for a phase II study on Proellex for the treatment of symptomatic fibroids.
The FDA also provided guidance related to the proposed uterine fibroid phase II protocol. The FDA specified appropriate enrollment criteria, preferred efficacy endpoint (reduction in excessive menstrual bleeding associated with uterine fibroids) and preferred methodology to determine changes in bleeding.
Repros plans to comply with the FDA guidance. We remind investors that in 2009 data from a phase III efficacy study and phase III safety studies revealed that Proellex (50 mg) was associated with liver toxicity. Consequently, the company stopped these studies and the FDA had placed a clinical hold on Proellex. On Oct 8, 2012, the FDA lifted the full clinical hold and placed a partial clinical hold on low dose oral Proellex (12 mg).
Repros currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks include Alexion Pharmaceuticals, Inc. (ALXN - Free Report) , Alkermes (ALKS - Free Report) and Gilead Sciences Inc. (GILD - Free Report) . All these stocks carry a Zacks Rank #1 (Strong Buy).