RALEIGH, N.C., Sept. 18, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals is pleased to announce a new partnership with Numan, a leading UK-based, VC-backed digital health platform, to introduce KYZATREX® (testosterone undecanoate) CIII capsules into Numan’s product offerings. KYZATREX is FDA-approved in the US and is indicated for adult men who have low or no testosterone due to certain medical conditions. This collaboration marks a significant step forward in the treatment of testosterone deficiency, offering men a more comprehensive and patient-centered solution for managing this common yet often overlooked condition.
Testosterone deficiency (TD) is a rising global epidemic, affecting approximately four in ten men over the age of 45 and 30-50% of men with obesity or type 2 diabetes, according to the Endocrine Society.1,2 In the UK alone, it is estimated that around 3 million men suffer from testosterone deficiency, with around 90% of those cases remaining untreated.3-5 TD is bi-directional with metabolic diseases, and early research suggests it may play a role in further conditions such as depression and inflammatory diseases. As these health issues continue to escalate, the partnership between Marius Pharmaceuticals and Numan marks a collaborative effort to position KYZATREX as a promising solution in the fight against this widespread medical condition.
“We are thrilled to partner with Numan and expand the availability of KYZATREX to patients in the UK,” said Amit Shah, Chief Operating Officer at Marius. “Testosterone deficiency is a global health issue, and our collaboration allows us to offer men a therapy that is not only effective but also designed with patient safety in mind. By joining forces with a trusted health platform like Numan, we’re confident that more men will have access to the care they need to improve their overall health and well-being.”
KYZATREX has been specifically formulated to be gentle on the body, bypassing the liver to prevent potential liver damage, a common concern with other forms of testosterone therapy. In a six-month clinical trial involving 139 men with low testosterone, 88% of KYZATREX patients achieved normal testosterone levels by Day 90 (worst-case scenario calculation, excluding Site 104). For patients who completed the study (n=127), this number rose to 96%. Furthermore, KYZATREX patients experienced a twofold increase in Free Testosterone levels and a 30% reduction in Sex Hormone Binding Globulin (SHBG) levels.6-8
Numan, already a leader in the medical weight loss space in the UK, brings a unique, patient-focused approach to testosterone therapy. Their process includes a holistic, guideline-led diagnosis using gold-standard blood testing and expert analysis. By integrating KYZATREX into their offerings, Numan continues to expand its commitment to men's health, delivering tailored treatment programs that address the root causes of testosterone deficiency and support overall wellbeing.
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.
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) and 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 symptoms of low testosterone, including quality of life, energy/fatigue, erectile function, sexual intercourse, and 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 for KYZATREX below, including Boxed Warning for potential increased blood pressure, or visit www.kyzatrex.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®
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 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:
- Mulligan T et al. “Prevalence of hypogonadism in males aged at least 45 years: the HIM study.” International journal of clinical practice vol. 60,7 (2006): 762-9. doi:10.1111/j.1742-1241.2006.00992.x.
- “Hypogonadism in Men.” Endocrine Society, Endocrine Society, 31 Mar. 2022, www.endocrine.org/patient-engagement/endocrine-library/hypogonadism.
- Hackett, Geoffrey et al. “The British Society for Sexual Medicine Guidelines on Male Adult Testosterone Deficiency, with Statements for Practice.” The world journal of men's health vol. 41,3 (2023): 508-537. doi:10.5534/wjmh.221027
- “England Population by Age Group 2022.” Statista, 4 July 2024, www.statista.com/statistics/281208/population-of-the-england-by-age-group/.
- Layton, J Bradley et al. “Testosterone lab testing and initiation in the United Kingdom and the United States, 2000 to 2011.” The Journal of clinical endocrinology and metabolism vol. 99,3 (2014): 835-42. doi:10.1210/jc.2013-3570
- Bernstein JS, Dhingra OP. A Phase III, Single-Arm, 6-Month Trial of a Wide-Dose Range Oral Testosterone Undecanoate Product. Therapeutic Advances in Urology. 2024;16.
- KYZATREX [prescribing information]. Raleigh, NC: Marius Pharmaceuticals; 2022.
- Data on file. Raleigh, NC: Marius Pharmaceuticals, 2020.
Media Contacts:
Marius Pharmaceuticals
Lilly Washburn
lilly@mariuspharma.com
