FDA’s Tough Stance On Patient-Reported Outcomes Underscored At Repros Meeting

 
• By Sue Sutter
  
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US FDA advisory committee's insistence on symptom benefit as an efficacy endpoint for obesity-related secondary hypogonadism highlights importance of Repros' current efforts to lay groundwork for a patient-reported outcomes instrument for further study of enclomiphene.

An FDA advisory committee's clinical development recommendations for hypogonadism treatments suggests Repros Therapeutics Inc. will face challenges in designing a new study with endpoints sufficient to support regulatory approval of its estrogen antagonist enclomiphene. And the committee’s surprised reaction to FDA’s stringency on patient-reported outcomes (PROs) underscores just how difficult the emerging area can be for sponsors.

Given the panel's emphasis on the need for data on PRO symptom improvement, coupled with its rejection of Repros' proposed...

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