Marius Pharmaceuticals Expands Access of KYZATREX™ (testosterone undecanoate) to Department of Veterans Affairs (VA), Pledging Support for Proper Hormonal Balance Among Military Personnel
News provided byMarius Pharmaceuticals LLC
Sep 19, 2023, 9:30 AM ET
RALEIGH, N.C., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, is proud to announce the expansion of access to its FDA-approved oral testosterone therapy, KYZATREX™, to the Department of Veteran Affairs (VA). This initiative is a significant milestone in Marius Pharmaceutical’s ongoing mission to provide accessible and life-enhancing therapies to focused communities.
Military personnel face an array of physical and psychological health challenges, including but not limited to stress, insomnia, emotional distress, and physical injuries. Veterans often endure unresolved health implications, including mental health conditions, that are frequently linked to low testosterone. A lack of awareness about the impacts of military service on both hormone health and symptom stigma makes it difficult for veterans to confront low testosterone.
Studies have shown that the stress associated with intense military field training can result in up to a 47% decrease in testosterone levels. With increased education and awareness about this connection, veteran mental and physical health can be addressed.
Marius Pharmaceuticals is committed to offering a safe and accessible oral solution with KYZATREX™. By providing a trusted therapy like KYZATREX™, Marius aims to not only enhance the long-term quality of life for these individuals but also contribute to the savings to the U.S. Healthcare system.
“At Marius Pharmaceuticals, we are proud to offer a treatment option to our veterans who have suffered from the physical and mental conditions associated with Low T, while bringing awareness of their plight to countless others who might not have realized the connection. Early diagnosis and treatment can reduce or eliminate downstream expenses freeing up budget dollars to help more veterans obtain the help they deserve,” shared Rich Callaghan, SVP, Operations at Marius Pharmaceuticals.
As part of its comprehensive effort to raise awareness about testosterone deficiency or hypogonadism, Marius Pharmaceuticals has launched the ReThink Testosterone disease state awareness initiative and website. ReThink Testosterone is committed to educating individuals, including veterans and active-duty service members, about the impact of low testosterone on overall health and well-being. The initiative will continue to expand its content and resources to provide valuable information on this critical topic.
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.
About ReThink Testosterone:
ReThink Testosterone is a disease state awareness campaign that aims to transform lives through education and support for individuals affected by low testosterone or Low T (male hypogonadism). Its mission is to enhance understanding of the symptoms, impact, and available treatment options for this condition, empowering men to make informed decisions about their health and well-being. For more information, please visit www.rethinktestosterone.com.
Important Safety Information for KYZATREX™ (testosterone undecanoate)
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™
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™.
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