FDAnews Drug Daily Bulletin

FDA Maintains Partial Clinical Hold on Repros’ Proellex

July 25, 2017

The FDA told Repros Therapeutics a partial clinical hold on its Proellex treatment for endometriosis and uterine fibroid symptoms will remain in place until the company compiles a broad safety database.

Discussions with the FDA suggest a much larger clinical trial will likely be necessary, according to Repros CEO Larry Dillaha.

The company said it will likely increase its focus on developing vaginal delivery systems for its endometriosis and uterine fibroid programs, rather than Proellex, which is an oral drug.

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