FDA expresses doubt about Repros' Proellex

The FDA has informed Repros Therapeutics (RPRX) that it will need to resolve a number of outstanding issues with its drug Proellex before the clinical hold on the drug can be lifted. In August, Repros Therapeutics suspended dosing in all clinical trials of the Phase III drug after increased liver enzymes were observed in a number of patients taking the drug. Proellex is being investigated as a treatment for symptoms of uterine fibroids and endometriosis.

Specifically, the FDA wants Repros to follow up with the patients who had elevated liver enzymes and identify a dosing regimen to investigate the efficacy of Proellex, among other tasks. But the agency said in its letter to the company that it doubts whether Proellex will be able to find a dosing regiment that is both safe and effective. And even if Repros were able to mount a new dose-finding study, it lacks the resources to conduct such a trial. Short on cash, Repros says its best bet now is to license the drug to a partner with the money necessary to continue development

The company also announced this morning that board member and Medical Director for Oncology Dr. Stephen Howell resigned from his position on the board as well as his role as Medical Director.

- take a look at the release from Repros
- here's the Reuters report