RALEIGH, N.C., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, has released compelling new insights from a recent Androgen Deficiency in Aging Males (qADAM) questionnaire conducted on their KYZATREX® (testosterone undecanoate) CIII capsules website. The data collected from 779 participants highlights significant challenges faced by men regarding energy, libido, strength and overall life satisfaction, underscoring the potential impact of testosterone deficiency on quality of life and well-being.
Below are the results from men who responded to the qADAM questionnaire, a validated tool for assessing testosterone deficiency symptoms:
- 75% rated their libido as poor or terrible
- 76% rated their energy level as poor or terrible
- 66% rated their strength and/or endurance as poor or terrible
- 62% rated their enjoyment of life as poor or terrible
- 46% rated their happiness level as poor or terrible
- 72% rated the strength of their erections as somewhat or extremely weak
- 53% rated their work performance over the past 4 weeks as poor or terrible
- 59% fall asleep at least 3-4x/week after eating dinner
- 72% rated their sports ability over the past 4 weeks as poor or terrible
"This data reinforces the necessity for greater awareness and resources to address men's health concerns, particularly testosterone deficiency, which can profoundly affect physical and emotional well-being," said Amit Shah, Chief Operating Officer of Marius Pharmaceuticals. "At Marius, we are committed to providing safe, effective options for managing low testosterone with products like KYZATREX."
KYZATREX is an FDA-approved oral form of testosterone replacement therapy (TRT) indicated for adult males experiencing low or no testosterone due to certain medical conditions. A six-month clinical trial demonstrated that KYZATREX was up to 96% effective at Day 90 at restoring normal testosterone levels in adult men who have low or no testosterone levels due to certain medical conditions.1,2*
*Per label, 88% of patients had low 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
Testosterone deficiency, also known as hypogonadism, affects millions of men worldwide and is associated with various chronic conditions, including obesity, diabetes and depression.3,4 As the global demand for men's health solutions grows, Marius Pharmaceuticals continues to prioritize patient-centered therapies, empowering men to take control of their health and well-being.
For more information on KYZATREX, visit www.kyzatrex.com.
About Marius Pharmaceuticals
Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company's 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®
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.
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).
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 visiting www.mariuspharma.com.
Keep KYZATREX and all medicines out of the reach of children.
See Full Prescribing Information and Medication Guide for KYZATREX.
References:
- KYZATREX [prescribing information]. Raleigh, NC: Marius Pharmaceuticals; 2022.
- Data on file. Raleigh, NC: Marius Pharmaceuticals, 2020.
- "Hypogonadism in Men.” Endocrine Society, 31 Mar. 2022, www.endocrine.org/patient-engagement/endocrine-library/hypogonadism.
- Shores MM, Sloan KL, Matsumoto AM, et al. Increased incidence of diagnosed depressive illness in hypogonadal older men. Arch Gen Psychiatry. 2004;61(2):162-167.
Marius Pharmaceuticals
Lilly Washburn
