JATENZO, once approved by the FDA, will be a new proprietary oral T formulation in the United States to treat men diagnosed with symptomatic T deficiency -- a medical condition known as hypogonadism. In our two completed Phase 3 trials, JATENZO met its primary endpoint of restoring T to normal levels in at least 75% of subjects. JATENZO will not have the risk of T transference to women and children, a risk associated with the market-leading T gels. We believe that JATENZO's oral administration will be more convenient than currently approved T-replacement therapies thus making it more likely that men will adhere to their T therapy.
JATENZO has been evaluated in two Phase 3 clinical trials in which the primary efficacy endpoint, namely restoration of serum T to the normal range of 300-1000 ng/dL, was achieved in in 84% and 75% of men, respectively. On the basis of these data, Clarus filed an NDA in early 2014 and was called upon by FDA to participate in an Advisory Committee on September 18, 2014. The Advisory Committee felt additional efficacy and safety data were needed and FDA affirmed this conclusion by issuing a complete response letter. Clarus has worked with the FDA to design a new Phase 3 trial (the inTUne trial) that we believe will provide the basis for approval of JATENZO. This trial is actively enrolling subjects in numerous sites across the U.S. Please see www.clinicaltrials.gov for more information.