Whole Health Rx now provides access to FDA-approved KYZATREX® (testosterone undecanoate) CIII capsules

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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, 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.3 Testosterone deficiency is bi-directional with metabolic diseases and early research indicates a role in further conditions such as depression and inflammatory diseases.
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"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.
 
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*Our TRT subscriptions are currently unavailable in NY, NJ, RI, CT, SC and AL.



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