FDA Puts Repros’ Proellex On Clinical Hold

FDA has placed Repros’ Proellex on clinical hold for safety reasons. This action follows the company’s voluntary decision to suspend dosing of all patients in clinical trials of Proellex.

The decision was based on the information regarding the occurrence of clinically significant increases in liver enzymes with 50mg and 25mg doses of Proellex, coupled with recent input from a consulting panel of liver experts.

FDA requested the company to provide weekly updates about the patients who experienced a serious adverse event and still have elevated liver enzymes.

The company and the FDA are scheduled to discuss the safety of Proellex and the overall direction and scope of the clinical trials at a meeting in late September.

At the September meeting, Repros plans to present a detailed analysis of all of the patients with elevated liver enzymes, discuss the events that led to the suspension of the clinical trials, and determine whether and under which conditions, the clinical hold may be lifted and the trials of Proellex be safely resumed.