Clarus Therapeutics re-submits NDA at FDA for Jatenzo (formerly Rextor), the Company's oral testosterone (T) replacement product.

Clarus Therapeutics, Inc.,announced the re-submission of its New Drug Application (NDA) for Jatenzo (formerly Rextor), the Company's oral testosterone (T) replacement product for the treatment of low testosterone in hypogonadal men, to the 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 III clinical investigation of its oral Testosterone Undecanoate product (the "inTUne" Trial) in which 87% of men treated with Jatenzo achieved average circulating levels of testosterone 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 testosterone levels were closely aligned with FDA targets. The safety profile of Jatenzo was consistent with data generated in two earlier Phase III trials and the general safety profiles for testosterone replacement products as a therapeutic class. Importantly, the inTUne Trial confirmed the efficacy of Jatenzo that was demonstrated in an earlier Phase III trial and further refined the dose adjustment scheme.

Comment: Jatenzo is an oral T therapy to be introduced in a market where currently available products are transdermal or injectable. The intention is to add convenience and a possible improvement to adherence as well as a safety factor of avoiding the accidental transfer of testosterone to woman or children that can occur with transdermal products.