Clarus Re-submits JATENZO NDA Following Positive Results of inTUne Trial
87% of Hypogonadal Men Treated with JATENZO in Confirmatory Phase 3 Study Achieved Average Circulating Testosterone Levels in Normal Range
NORTHBROOK, Ill – June 26, 2017 -- Clarus Therapeutics, Inc., today announced the re-submission of its New Drug Application (NDA) for JATENZO™ (formerly Rextoro™), the Company's oral testosterone (T) replacement product for the treatment of low testosterone in hypogonadal men, to the U.S. Food and Drug Administration (FDA). The new submission addresses all points raised by the FDA in the Complete Response Letter (CRL) issued to Clarus.
Clarus conducted a new Phase 3 clinical investigation of its oral Testosterone Undecanoate product (the "inTUne" Trial) in which 87% of men treated with JATENZO achieved average circulating levels of T in the normal range based on the primary efficacy analysis mandated by FDA. All sensitivity analyses yielded similar efficacy (range: 86–90%). In addition, peak T levels were closely aligned with FDA targets. The safety profile of JATENZO was consistent with data generated in two earlier Phase 3 trials and the general safety profiles for T replacement products as a therapeutic class. Importantly, the inTUne Trial confirmed the efficacy of JATENZO that was demonstrated in an earlier Phase 3 trial and further refined the dose adjustment scheme.
"We believe the completeness and strength of our NDA re-submission will provide FDA with the information it needs to approve JATENZO," said Dr. Robert E. Dudley, Clarus' President and Chief Executive Officer. "Clarus developed JATENZO to address a void in treatment options for low testosterone in hypogonadal men and their healthcare providers created by currently available transdermal and injectable products that account for the vast majority of testosterone replacement product prescriptions. To date, Clarus has three Orange Book listable patents covering JATENZO with the last of these patents expiring well into 2030."
According to Dr. Theodore M. Danoff, Clarus' Senior Vice President for Clinical and Medical Affairs and Chief Medical Officer, "An oral T-replacement product would not only be convenient, but would avoid many of the safety issues associated with accidental transfer of T to women or children that can occur from transdermal T products. Moreover, published data indicates that men on transdermal T products often do not adhere to their treatment plan and we believe an oral option may improve this."
About Clarus Therapeutics
Clarus is an emerging men's specialty pharmaceutical company developing and preparing for the commercial launch of JATENZO, a- proprietary oral testosterone replacement therapy protected by patents issued in the United States and in other major pharmaceutical markets around the world. JATENZO is a T prodrug that, if approved by the FDA, could be the first oral testosterone prodrug available to treat men diagnosed with testosterone deficiency together with an associated medical condition, also known as hypogonadism. Clarus owns the worldwide, royalty-free commercialization rights for JATENZO. For more information, please visit: www.clarustherapeutics.com.