Repros (RPRX) Updates on Oral Proellex; Says FDA May Upgrade on New Phase 2 Protocol
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Repros Therapeutics Inc. (Nasdaq: RPRX) 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.
Joseph Podolski, President and CEO of Repros commented, "We appreciate the timely review of our safety analysis by the FDA and are pleased with the guidance that they provided. We agreed with their suggestions on the design of the study and plan to commence the Phase 2 study as soon as possible."
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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.
Joseph Podolski, President and CEO of Repros commented, "We appreciate the timely review of our safety analysis by the FDA and are pleased with the guidance that they provided. We agreed with their suggestions on the design of the study and plan to commence the Phase 2 study as soon as possible."
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