FDA Provides Guidance to Repros for the Conduct of a Phase 2 Study of Low Dose Oral Proellex in the Treatment of Endometriosis

Repros Therapeutics Inc.®

today announced it held a teleconference with the FDA to discuss the development of oral Proellex® as a treatment for endometriosis. The FDA has agreed to update the full clinical hold to a partial clinical hold once they have reached agreement with Repros on the design of a Phase 2 study protocol. The Company plans to submit the study protocol to the FDA in the next several days. The FDA had previously requested an integrated safety analysis of completed studies of oral Proellex® for review prior to the continuation of the oral program. In the teleconference, the FDA made several recommendations on the study design and suggested that both a 6 and 12 mg dose of Proellex® be included in the study.