CORRECTION — Marius Pharmaceuticals Receives FDA Approval of KYZATREX™, an Oral Testosterone Replacement Therapy



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RALEIGH, NC, Sept. 21, 2022 (GLOBE NEWSWIRE) — In a press release dated August 2, 2022 by Marius Pharmaceuticals under the same heading, please note that the correct number for reporting adverse reactions to KYZATREX™ to Marius 1- is. 833-949-5040. The corrected release follows:

Marius Pharmaceuticals, a patient-centric healthcare company, today announced U.S. Food and Drug Administration (FDA) approval of KYZATREX™ (testosterone undecanoate). KYZATREX™ is an oral testosterone replacement therapy (“TRT”) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. The approval of KYZATREX™ offers an important option for the treatment of hypogonadism, or better known as testosterone deficiency, which affects approximately 40% of men over the age of 45 and 30-50% of men with obesity or type 2 diabetes1. KYZATREX™ has been approved in three dosage strengths, 100 mg, 150 mg and 200 mg.

“I want to congratulate our scientific team on this important milestone, and now it’s up to our commercial team to make KYZATREX™ a leading therapy and a popular brand for millions of hypogonadal men in the United States. Low testosterone affects numerous metabolic factors as well as true quality of life often overlooked, so annual testosterone testing should be mandatory for men over 40,” noted Himanshu H. Shah, Chairman of Marius.

KYZATREX™ is a proprietary oral softgel capsule that absorbs primarily via the lymphatic system, avoiding liver toxicity. The oral method of administration eliminates the risk of application site reactions common with intramuscular testosterone injections, as well as possible transmission to women or children that can occur with topical testosterone gels and creams. When taken daily, morning and night (with food), KYZATREX™ better mimics the daily rhythm of natural testosterone production compared to long-acting therapies.

“With so many men suffering from testosterone deficiency on a daily basis, often avoiding or opting out of treatment, we see FDA-cleared KYZATREX™ as a new viable oral option that has proven to be safe and effective. Additionally, testosterone deficiency is a major blind spot in medicine today, and our research will continue to explore the importance of testosterone in both male and female health,” commented Shalin Shah, CEO of Marius.

KYZATREX™ has the potential to become the new gold standard for treating patients with hypogonadism. At least six million symptomatic men have hypogonadism in the US and over 100 million men worldwide.

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Please see additional important safety information for KYZATREX™ below.


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About testosterone and hypogonadism

Hypogonadism, often referred to as testosterone deficiency, is a condition that occurs when the body does not produce adequate levels of testosterone. Primary hypogonadism (failure of the testicles due to certain medical conditions) and hypogonadotropic hypogonadism both result in low serum testosterone concentrations. In addition to testosterone’s widely accepted role in sexual and reproductive function, it also plays an important role in numerous other metabolic and inflammatory processes and is one of the most common causes of secondary osteoporosis in men. Patients with hypogonadism may experience fatigue, lack of energy, decreased muscle mass, weight gain, low libido, poor cognition, trouble sleeping, and other mood disorders such as depression and anxiety. Because low testosterone levels can also increase the risk of developing type 2 diabetes and obesity, hypogonadism is a common comorbidity in a broader range of conditions, including type 2 diabetes and nonalcoholic steatohepatitis (NASH).

About KYZATREX™

KYZATREX™ is a proprietary oral softgel formulation that is primarily absorbed via the lymphatic system (meaning it is non-toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone are. The safety and efficacy of KYZATREX™ was established in a multicenter, open-label, six-month, Phase 3 study in 155 hypogonadal men, ages 18 to 65, with documented hypogonadism, defined by below-normal serum testosterone levels (≤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 (Caverage) over 24 hours within the normal range (222-800 ng/dl) at the last pharmacokinetic (PK) assessment of the study at day 90 (primary endpoint). Based on exploratory endpoints, patients receiving KYZATREX™ reported improvements in quality of life, energy/fatigue, erectile function, sexual satisfaction and positive mood. The most common adverse reaction reported in ≥ 2 percent of KYZATREX™ patients was increased blood pressure (2.6%). The safety and effectiveness of KYZATREX™ in men under the age of 18 have not been established.

Please see the additional important safety information below for KYZATREX™, including the boxed warning of potentially elevated blood pressure.

About Marius Pharmaceuticals

Marius Pharmaceuticals is a patient-centric healthcare company focused on therapies designed for hypogonadism, or testosterone deficiency. The company’s mission is to improve the functional lives of patients by reducing the downstream effects of testosterone deficiency, which includes multiple comorbidities such as type 2 diabetes and obesity. Visit www.mariuspharma.com for more information

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Important Safety Information for KYZATREX™ (Testosterone Undecanoate)

Use

KYZATREX™ (Testosterone Undecanoate) is a prescription medication 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 men under the age of 18. Improper use can affect bone growth in children. KYZATREX™ is not intended for use by women.

Important Safety Information for KYZATREX™

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

  • If your blood pressure rises during treatment with KYZATREX™, you may need to start blood pressure medication. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines added to control your blood pressure.
  • If your blood pressure cannot be controlled, KYZATREX™ may need to be discontinued.
  • Your doctor will monitor your blood pressure while you are being treated with KYZATREX™.

Do not take KYZATREX™ if you: have breast cancer; have or may have prostate cancer; are a pregnant woman (KYZATREX™ may harm your unborn baby); are allergic to KYZATREX™ or any of its ingredients; or have low testosterone without a specific medical condition (eg, do not take KYZATREX™ if you have low testosterone due to age).

Before taking KYZATREX™, tell your doctor about all your medical conditions, including if you have: have high blood pressure or are being treated for high blood pressure; have a history of diabetes; have heart problems; have a 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 trouble breathing during sleep (sleep apnoea).

Tell your doctor about all medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX™ with certain other medicines can interfere with each other. In particular, tell your doctor if you are taking it: insulin; Medicines that reduce blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold and pain relievers.

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KYZATREX™ can cause other serious side effects, including:

  • Increase in the number of red blood cells (hematocrit) or hemoglobin, which can increase the risk of blood clots, stroke and heart attack. You may need to stop KYZATREX™ if your red blood cell count increases.
  • if she beautiful to have a enlarged Prostate, your sign and symptoms can deteriorate while take KYZATREX™. These may include: increased urination at night; difficulty starting your urine stream; urinating several times a day; urge to go to the toilet immediately; a urinary accident; Inability to pass urine or poor flow of urine.
  • Increased risk of prostate cancer.
  • blood clot in the Legs or lung. Signs and symptoms of a blood clot in your leg may include pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs may include difficulty breathing or chest pain.
  • abuse. Testosterone can be abused when taken in higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious cardiac and psychological side effects.
  • In large doses, KYZATREX™ can decrease your sperm count counting.
  • liver problems. Symptoms of liver problems may include: feeling sick or being sick; yellowing of your skin or the whites of your eyes; dark urine; Pain in the right side of your stomach area (stomach ache).
  • Swelling of your ankles, feet or body (oedema) with or without heart Fail.
  • Enlarged or painful breasts.
  • Breathing problems during sleep (sleep apnea).

Contact your doctor 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, leg swelling, and increased levels of prostate specific antigen (PSA).

These are not all of the possible side effects of KYZATREX™. For more information, contact your doctor 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 can also report side effects to Marius by calling 1-833-949-5040.

Keep KYZATREX™ and all medicines out of the reach of children.
See complete Prescribing Information and Medication Guide for KYZATREX™.

Media contact: Lilly Washburn [email protected]

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/ba2569ca-0922-4b49-8d68-49424b5e44d4

https://www.globenewswire.com/NewsRoom/AttachmentNg/f825d70b-874a-4cef-9160-429f83bbfc66






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