Clarus Therapeutics re-submits NDA following positive Phase III results

A New Drug Application (NDA) for Jatenzo (formerly Rextoro), US biotech firm Clarus Therapeutics’ oral testosterone (T) replacement product for the treatment of low testosterone in hypogonadal men, has been re-submitted, to the US Food and Drug Administration.

The new submission addresses all points raised by the FDA in the Complete Response Letter (CRL) issued to Clarus.

Clarus says it 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 T in the normal range based on the primary efficacy analysis mandated by the 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 III 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 III trial and further refined the dose adjustment scheme.