FDA Advisory Committee does not approve Jatenzo to treat hypogonadism in adult males.

The Bone, Reproductive, and Urologic Drugs Advisory Committee split on whether to recommend oral testosterone undecanoate capsule, Jatenzo from Clarus Therapeutics, for the treatment of hypogonadism in adult males. That vote was 10-9 against approval.

This is the second advisory committee review of Clarus' Jatenzo following an initial negative vote in September 2014, which led to the FDA denying approval that November. The agency told Clarus it would have to conduct a new phase III trial to address prior concerns in order to include food effect data, a revised starting dose and titration regimen, and ambulatory blood pressure monitoring.

The clinical development program for Jatenzo included 10 studies, involving a total of 569 adult hypogonadal men, who received the investigational drug. The comparator group consisted of 215 men who received transdermal testosterone (Axiron). The studies included six phase II studies, and three phase III dose-titration analyses, along with the 2-month safety extension study.