Marius Pharmaceuticals Submits KYZATREX® (Testosterone Undecanoate) CIII Capsules for Approval to Health Canada

RALEIGH, N.C., July 30, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a patient-centric healthcare company focused on developing innovative therapies for Testosterone Deficiency, is pleased to announce the submission of its New Drug Submission (NDS) for KYZATREX^® (testosterone undecanoate) CIII capsules to Health Canada for approval. This submission marks the company's first international filing, with an anticipated approval date in Q2 of 2025.

KYZATREX is an oral testosterone replacement therapy designed to treat adult men with low or no testosterone levels due to certain medical conditions. KYZATREX offers a convenient and effective alternative in the form of a softgel capsule, which is absorbed primarily via the lymphatic system, thereby avoiding liver toxicity. If approved, KYZATREX could become the only oral testosterone option available in Canada. KYZATREX received U.S. FDA approval in July 2022.

“We are excited by this first international filing and look forward to helping more patients by broadening the availability of oral testosterone. Our goal is to provide men worldwide with access to effective, convenient treatment options for testosterone deficiency,” said Nita Nimmons, Director of Quality and Regulatory at Marius Pharmaceuticals. “Testosterone is a critical metabolic hormone that is crucial for many functions in the body. We hope that by increasing access to KYZATREX, we can become part of a solution to what has become a worldwide men’s health crisis.”

KYZATREX Clinical Trial Highlights:

Up to 96% Efficacy¹In a six-month clinical trial of 139 men with low testosterone, 88% of patients had normal testosterone levels at Day 90 (worst-case scenario calculation, excluding Site 104). Based on patients who completed the study (n=127), 96% of patients achieved normal testosterone levels at Day 90.¹

Safety Profile
Only one drug-related adverse event was observed in more than 2% of study participants: hypertension (2.6%).¹

2x Increase in Free Testosterone¹
Mean Free Testosterone levels increased from 7.0 ng/dL to 14.1 ng/dL after 90 days of treatment.

The Impact of Low Testosterone on Men’s Health in Canada
Testosterone deficiency, or hypogonadism, is a chronic condition that affects over twenty million men in the United States and millions more worldwide.^2,3 In Canada, the prevalence of testosterone deficiency is significant. Approximately 25% of Canadian men aged 40–62 years are estimated to have testosterone deficiency, with rates increasing with age.⁴Moreover, the Canadian Men's Health Foundation reports that nearly 50% of Canadian men aged 40–88 experience erectile dysfunction, a condition often associated with low testosterone levels.⁵

Low testosterone is commonly associated with sexual health, but its impacts extend far beyond. It has significant effects on physical, cardiovascular, cognitive, and metabolic health, including obesity, type 2 diabetes, depression, osteoporosis, inflammation, and muscle wasting (sarcopenia). Addressing this condition effectively is crucial to improving the overall health and well-being of men, and reducing the broader healthcare burden.

“Marius anticipates that Canadian healthcare will mirror the advancements seen in American healthcare, particularly in the realms of health, wellness, and telehealth,” said Amit Shah, the COO of Marius Pharmaceuticals. “The introduction of KYZATREX into the Canadian market is poised to support this progressive vision, offering a comprehensive approach to addressing testosterone deficiency and enhancing the overall health of men.”

About KYZATREX® (testosterone undecanoate)
KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established.

Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX or visit www.kyzatrex.com.

About Marius Pharmaceuticals
Marius Pharmaceuticals strives to better the lives of men and women by focusing on therapies designed for hypogonadism or Testosterone Deficiency. Their vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.

Important Safety Information for KYZATREX® (testosterone undecanoate)

Use
KYZATREX (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.

Important Safety Information for KYZATREX® (testosterone undecanoate)

KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
If your blood pressure cannot be controlled, KYZATREX may need to be stopped.
Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX.

Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age).

Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX may cause other serious side effects including:

Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.
If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
Increased risk of prostate cancer.
Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
In large doses, KYZATREX may lower your sperm count.
Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
Swelling of your ankles, feet, or body (edema), with or without heart failure.
Enlarged or painful breasts.
Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040.

Keep KYZATREX and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX.

References:

Bernstein JS, Dhingra O. "A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product." Ther Adv Urol. 2024;16:1-17. 2024; doi:10.1177/17562872241241864
Yongchao L, Minghui L, et al. Increased risk of testosterone deficiency is associated with the systemic immune-inflammation index: a population-based cohort study. Front. Endocrinol. 13:975773. doi: 10.3389/fendo.2022.974773
National Population by Characteristics: 2020-2022. Annual Estimates of the Resident Population for Selected Age Groups by Sex for the United States: April 1, 2020 to July 1, 2022 (NC-EST2022-SYAEXN). U.S. Census Bureau. https://www.census.gov/data/tables/time-series/demo/popest/2020s-national-detail.html
Morley, J E et al. “Validation of a screening questionnaire for androgen deficiency in aging males.” Metabolism: clinical and experimental vol. 49,9 (2000): 1239-42. doi:10.1053/meta.2000.8625
“Erectile Dysfunction Info for Men: Causes, Prevention, Treatment.” Edited by Dr. Larry Goldenberg, Canadian Men’s Health Foundation, 28 Mar. 2024, menshealthfoundation.ca/mens-health-conditions/erectile-dysfunction/.

Media Contact:
Lilly Washburn
lilly@mariuspharma.com
(336) 404-9622