The Vitamin Shoppe® Expands its Whole Health Rx™ Telehealth Offering into Testosterone Replacement Therapy via a Partnership with Marius Pharmaceuticals for its KYZATREX® (Testosterone Undecanoate) CIII Capsules

News provided by

Sep 03, 2024, 08:30 ET

The new partnership offers trusted and convenient telehealth access to treatment for the millions of American men who experience testosterone deficiency and may be appropriate patients for KYZATREX

SECAUCUS, N.J., Sept. 3, 2024 /PRNewswire/ -- The Vitamin Shoppe^®, an omni-channel specialty retailer of nutritional products, today announced the expansion of its telehealth service, Whole Health Rx™ by The Vitamin Shoppe, with the launch of prescription Testosterone Replacement Therapy (TRT) solutions. Partnering with Marius Pharmaceuticals, Whole Health Rx now provides access to FDA-approved KYZATREX^® (testosterone undecanoate) CIII capsules, a prescription medication for adult men who have low or no testosterone due to certain medical conditions. KYZATREX is available in an oral form, providing a non-invasive and convenient alternative to traditional injection-based methods.

Whole Health Rx is an innovative telehealth service from The Vitamin Shoppe that offers a holistic approach to health solutions, now including prescription Testosterone Replacement Therapy (TRT).

Whole Health Rx is an innovative telehealth service from The Vitamin Shoppe that offers a holistic approach to health solutions, encompassing prescription medications, nutritional supplements for whole-body health, and expert guidance on lifestyle practices to support lifelong wellness. The service launched in May 2024, with an initial focus on GLP-1 agonist medications for weight loss.

Whole Health Rx enables access to a virtual care platform, powered by WellSync, which safely and seamlessly connects patients with licensed healthcare providers in real time, delivering a high standard of personalized care and prescription medications, with lower costs and greater convenience for patients.

Lee Wright, CEO of The Vitamin Shoppe, commented, "Men's health and testosterone support has been a category of growing interest to our customers, so we're especially pleased to now offer the highly effective and easy-to-use KYZATREX prescription medication to Whole Health Rx patients who can benefit from TRT. Our mission is to grow Whole Health Rx into a full-service health solution provider that can meet more of our customers' wellness needs, building on our strategic partnership with WellSync's innovative telehealth platform and expert network of healthcare professionals and pharmacies. As a pioneer in the wellness space since 1977, The Vitamin Shoppe is uniquely positioned to unite pharmaceutical interventions, such as TRT, with our unmatched expertise in nutrition support and whole-body health."

The launch of TRT on Whole Health Rx comes at a time when there are an estimated 20 million American men who experience Testosterone Deficiency (TD), or hypogonadism. TD is a rising global epidemic as it affects approximately four in ten men older than 45 years and 30-50% of men with obesity or type 2 diabetes, according to the Endocrine Society.^1,2 Between 10% and 40% of men worldwide suffer from low testosterone levels.³Testosterone deficiency is bi-directional with metabolic diseases and early research indicates a role in further conditions such as depression and inflammatory diseases.

"Testosterone Replacement Therapy can significantly improve energy levels, muscle mass, and libido in males with a diagnosed deficiency in their testosterone levels. It helps enhance mood, cognitive function, and overall well-being. Additionally, TRT can aid in reducing the risks of cardiovascular diseases by maintaining optimal hormone levels," said Mutahir Farhan, MD, a member of The Vitamin Shoppe's Wellness Council.

While TRT has traditionally consisted of injections, implanted pellets, patches, or gels, KYZATREX instead delivers testosterone through a twice-daily, softgel capsule that is safe and convenient. The oral delivery excludes the administration pain, mess, transference risk to others around you, and changes to eating habits which can occur with other TRT delivery systems. KYZATREX is primarily absorbed via the lymphatic system, effectively bypassing the liver and avoiding toxicity.

Shalin Shah, CEO of Marius Pharmaceuticals, commented, "We are excited that The Vitamin Shoppe is expanding Whole Health Rx to include KYZATREX, offering men a convenient and effective treatment for low testosterone. The data demonstrates that KYZATREX not only provides a safe and effective form of testosterone replacement therapy, but also decreases sex hormone-binding globulin (SHBG) and increases free testosterone levels in the body. By combining the convenience of our oral delivery system with the benefits of testosterone undecanoate, we believe KYZATREX can be transformative for men suffering from testosterone deficiency, addressing the significant drop in testosterone levels among men in the United States over the past few decades."

In a six-month clinical trial of 139 men with low testosterone, 88% of KYZATREX 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. Critically, KYZATREX patients also had a 2x increase in Free Testosterone levels and a 30% decrease in Sex Hormone Binding Globulin (SHBG) levels.^4-6

In a separate clinical study, KYZATREX patients (n=214) reported improvements in energy, positive mood, sexual desire, intercourse satisfaction, and social functioning, among other factors, as a result of improved testosterone levels compared to baseline.⁶(Exploratory endpoints from Study MRS-TU-2019; Different dosing scheme than MRS-TU-2019EXT. Results may not be clinically significant.)

Whole Health Rx patients are required to complete a medical history questionnaire and diagnostic blood tests, as well as meet virtually with a medical provider, to determine eligibility for a KYZATREX prescription. If approved for a prescription, orders will be easily and quickly fulfilled through Whole Health Rx's pharmacy partners and delivered in the mail.

Many men looking into TRT share common health factors, from diet and sleep issues to strength training and longevity goals. As a complement to TRT, Whole Health Rx includes easy access to education about lifestyle changes and proper nutrition that can support these kinds of whole-body health goals, as well as nutritionist-approved supplement options such as proteins, creatine, prostate support, and multivitamins.

For more information about TRT and Whole Health Rx by The Vitamin Shoppe, visit www.vitaminshoppe.com/trt. For more information about KYZATREX, visit www.kyzatrex.com, and for more information about Marius Pharmaceuticals, visit www.mariuspharma.com.

About The Vitamin Shoppe^®

Lifelong Wellness Starts Here™. The Vitamin Shoppe^®, a subsidiary of Franchise Group, Inc., is a global, omnichannel specialty retailer and wellness lifestyle Company with the mission of providing customers with the most trusted products, guidance, and services to support them on their journeys of lifelong wellness. Based in Secaucus, New Jersey, the Company offers a comprehensive assortment of nutritional solutions, including vitamins, minerals, sports nutrition, specialty supplements, herbs, homeopathic remedies, and green living products. In addition to carrying products from approximately 700 national brands, The Vitamin Shoppe offers products from its proprietary brands within its owned and wholesale channels, including: The Vitamin Shoppe^®, Vthrive The Vitamin Shoppe^®, BodyTech^®, BodyTech^® Elite, fitfactor™, fitfactor KETO™, plnt^®, ProBioCare^®, True Athlete^®, and TrueYou™. In the U.S., the Company conducts business through approximately 700 company-operated and franchise retail stores under The Vitamin Shoppe and Super Supplements™ banners, and via its website, www.vitaminshoppe.com. Globally, The Vitamin Shoppe serves customers in select Asia, South America, and Central America markets through local omnichannel partners.

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 WellSync

WellSync is a leader in healthcare innovation, revolutionizing the connection between providers and patients through our transformative, virtual-first platform. By leveraging advanced integrated technology, we seamlessly embed clinical and medication fulfillment services into any online environment. Our scalable, API-driven solution empowers companies to incorporate virtual healthcare services directly into their existing digital presence, enhancing patient access and unlocking new revenue streams. Our versatile platform stands out by its accessibility, personalization, and streamlined integration, supported by teams of top-tier healthcare professionals—including board-certified physicians, licensed specialists, and nurse practitioners—who bring extensive expertise and an unwavering commitment to exceptional patient care. Their dedication ensures our platform continually adapts to meet the ever-changing demands of healthcare in today's virtual landscape. WellSync isn't just redefining healthcare delivery, we're pioneering the future of digital health partnerships.

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 Capsules)

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.
Anaissie J et al. "Testosterone deficiency in adults and corresponding treatment patterns across the globe." Translational andrology and urology vol. 6,2 (2017): 183-191. doi:10.21037/tau.2016.11.16
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.