Robert E. Dudley, Ph.D. Chairman, Chief Executive Officer and President Clarus Therapeutics

Clarus Therapeutics Lauches JATENZO® – Oral Testosterone Replacement Therapy Interview with:

Robert E. Dudley, Ph.D. Chairman, Chief Executive Officer and President Clarus Therapeutics

Dr. Dudley

Robert E. Dudley, Ph.D.
Chairman, Chief Executive Officer and President
Clarus Therapeutics

Dr. Dudley discusses the recent announcement that Clarus Therapeutics, Inc. has launched  JATENZO® (testosterone undecanoate) capsules for the treatment of appropriate men with testosterone deficiency (hypogonadism): What is the background for this announcement?

Response: JATENZO® is the first and only oral softgel testosterone undecanoate and the first oral testosterone product approved by the U.S. FDA in more than 60 years. JATENZO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

The launch of JATENZO means that physicians and men living with testosterone deficiency due to genetic or structural abnormalities finally have a safe and effective oral testosterone replacement therapy. We are proud to commercially launch this unique oral formulation to healthcare providers and the appropriate patients who they treat. JATENZO is now available at pharmacies across the country. What are the main findings of the underlying studies?

Response: JATENZO was evaluated in a Phase 3 pivotal trial among 166 adult, hypogonadal men in a 4-month, open-label study with a topical testosterone comparator arm. The starting dose was 237 mg twice daily (BID) with meals. Dose adjustments (minimum 158 mg BID; maximum 396 mg BID) were made roughly 3 and 7 weeks after initiation of JATENZO based on average circulating testosterone concentration levels. 87% of JATENZO patients reached testosterone levels within the normal eugonadal range at the end of the study; peak testosterone levels were in close alignment with FDA targets.

Across all Phase 2 and Phase 3 trials combined, the safety of JATENZO has been evaluated in 569 patients who were treated with JATENZO for up to two (2) years. Liver toxicity was not observed with JATENZO in clinical trials.

Mild gastrointestinal adverse events observed with JATENZO were transient, manageable and did not lead to discontinuation. Decreased HDL cholesterol and increased hematocrit were associated with JATENZO use but did not lead to discontinuation of JATENZO. Only three of the 166 patients (1.8%) in the 4-month study experienced adverse reactions that led to premature discontinuation from the study, including rash (n=1) and headache (n=2). JATENZO was associated with an increase in systolic blood pressure. A boxed warning about the potential risks associated with elevated blood pressure appears on JATENZO labeling. Patients on JATENZO should have their blood pressure monitored.

Among the 569 patients who received JATENZO in all Phase 2 and 3 trials combined, the following adverse reactions were reported in >2% of patients: polycythemia, diarrhea, dyspepsia, eructation (i.e., burping), peripheral edema, nausea, increased hematocrit, headache, prostatomegaly (i.e., enlarged prostate), and hypertension. How does JATENZO® differ from other treatments for testosterone deficiency?

Response: The launch of JATENZO is an important step forward in testosterone replacement therapy. The only other oral testosterone replacement therapy product ever approved by the FDA is methyltestosterone (an alkylated androgen) that has been associated with serious liver toxicity and is rarely, if ever, used today. Because JATENZO is formulated as a lipophilic prodrug, it bypasses the first-pass hepatic metabolism. No liver toxicity-related events were observed in clinical studies of JATENZO – including in patients who took JATENZO at higher doses than recommended in current product labeling for two (2) years.

We believe JATENZO addresses a long-standing need for a safe and effective oral testosterone replacement product that meets current day FDA safety and efficacy standards. JATENZO enters a market where the vast majority of hypogonadal men are treated with injectable or topical testosterone products. JATENZO avoids administration challenges seen with these non-oral treatments – it presents no injection site pain, no transfer risk, no mess, no skin irritation and no surgical procedure. Therefore, we believe a significant number of hypogonadal men will prefer JATENZO as an alternative to other forms of testosterone therapy. How are men tested to determine if JATENZO® therapy is appropriate for them?

Response: According to the American Urological Association and Endocrine Society clinical guidelines, diagnosis of hypogonadism is determined by both the identification of symptoms and/or signs consistent with hypogonadism and blood test measurement of low morning total serum testosterone concentration (defined as <300 ng/dL, on two separate days). Healthcare providers should assess each patient individually for the appropriateness of JATENZO to treat their clinical hypogonadism. What else should readers take away from your report?

Response: Clinical hypogonadism can be more complex than most people realize and left untreated, can have a profound negative impact for the individual. Men with the symptoms of hypogonadism have a real medical need that deserves appropriate diagnosis and treatment.

Any disclosures?

Please click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure.





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Last Updated on February 19, 2020 by Marie Benz MD FAAD