The Dallas Based, Direct-to-Consumer Telemedicine Company Secures Marketing Agreement with Marius Pharmaceuticals Bringing KYZATREX to the Telehealth Market as 'Prime' by MangoRx
Dallas, Texas & Raleigh, NC, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Mangoceuticals, Inc. (NASDAQ: MGRX) ("MangoRx" or the "Company"), a company focused on developing, marketing, and selling a variety of men's health and wellness products via a secure telemedicine platform, including its uniquely formulated hair growth product ('GROW') and erectile dysfunction (ED) drug ('Mango'), is excited to announce that it has entered into a Marketing Agreement with Marius Pharmaceuticals ("Marius") to market and sell KYZATREX, an innovative FDA-approved oral Testosterone Replacement Therapy (TRT) product, under the program, 'PRIME' by MangoRx.
PRIME will be available on MangoRx's telemedicine platform with an anticipated launch date of January 31, 2024.
KYZATREX, a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions, is one of only three FDA approved TRT treatments that is delivered orally--as opposed to the traditional, invasive, and inconvenient injection-based drug delivery protocol. KYZATREX delivers testosterone in a softgel capsule that is absorbed primarily via the lymphatic system, avoiding liver toxicity.
Testosterone deficiency is often first recognized through symptoms of fatigue or low energy, decreased sex drive, lower muscle mass and many other negative downstream impacts. PRIME, powered by KYZATREX, can help men restore Testosterone to normal levels and improve how they feel. In a 6-month open-label clinical study of 139 hypogonadal patients, 88% of patients taking KYZATREX had normal testosterone levels at Day 90 (worst case scenario (WCS) efficacy calculation, excluding Site 104).1 Among study completers (n=127), 96% of KYZATREX patients achieved normal testosterone levels at Day 90.2 With PRIME, MangoRx will expand broad-based consumer access to this innovative therapy.
TRT treatments have traditionally been delivered through intramuscular needle injection, a subcutaneous implant, or a topical gel. These applications have suffered from different drawbacks depending on the delivery method, such as painful administration, uneven absorption, risk of transfer to others, and disruptions to the body's natural diurnal rhythm allowing for peak performance early in the day.
Twice daily oral TRTs offer painless administration, promote steady absorption, lower SHGB levels, increase free T levels to give the body more usable testosterone, and work with the body's natural diurnal rhythm. Oral softgels are also convenient, mess-free, and discreet.
Shalin Shah, CEO of Marius, shared, "This expansion into telehealth marks an important step in the care of Testosterone Deficient patients. Testosterone Deficiency is a serious chronic disease and has been inadequately addressed by previous generations of products. KYZATREX marks a shift in the treatment paradigm and a meaningful opportunity for patients seeking to restore optimal testosterone levels. Marius is excited to partner with MangoRx as an innovative partner in the DTC marketplace. We look forward to the Mango team bringing more awareness around the significance of Testosterone as a metabolic hormone and its role in optimal health for men with Low T."
PRIME by MangoRx will bring KYZATREX to patients spanning 48 states through the Company's telemedicine platform, which is optimized to deliver a smooth medical prescription process, including blood work and synchronous telehealth visits with a fully licensed prescribing physician. Orders will be reviewed and, pending approval, fulfilled, then discreetly shipped via MangoRx's URAC accredited mail order partner pharmacy directly to the patient's doorstep.
Jacob Cohen, MangoRx's Co-Founder and CEO, noted, "PRIME represents a critical expansion into a new vertical with massive market potential and very little competition on the consumer side, while remaining completely consistent with our established identity as a company committed to providing new and innovative pharmaceutical based solutions helping men achieve optimal performance in all areas of life. We are extremely fortunate to be working with Marius and to be one of only a few companies with access to this innovative product. With our established marketing and telemedicine infrastructure in place, we are ready to hit the ground running and take PRIME to patients in need across the country next month."
Testosterone deficiency 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.3,4 Between 10% and 40% of men worldwide suffer from low testosterone levels.5