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 ProfileOnly one drug-related adverse
event was observed in more than 2% of study participants:
hypertension (2.6%).1
- 2x Increase in Free
Testosterone1Mean 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
CanadaTestosterone 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.4 Moreover,
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
PharmaceuticalsMarius 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)
UseKYZATREX (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
Washburnlilly@mariuspharma.com(336) 404-9622