FDA issues Complete Response Letter to Repros Therapeutics in respect to enclomiphene for the treatment of secondary hypogonadism in overweight men.

Repros Therapeutics announced that it has received a Complete Response Letter from the FDA for its New Drug Application for enclomiphene for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. A Complete Response Letter is a communication from the FDA that informs companies that an application cannot be approved in its present form.

In the letter, the FDA stated that, based on recent scientific developments, the design of enclomiphene Phase III studies is no longer adequate to demonstrate clinical benefit and recommended that Repros conduct an additional Phase III study or studies to support approval in the target population. The FDA also noted concerns regarding study entry criteria, titration and bioanalytical method validation in the Phase III programme.