madman
Super Moderator
It was just a matter of time!
F**king A!
Looks like they may have beat out Verity Pharmaceuticals oral Tlando for dibs on the Canadian market!
RALEIGH, N.C., July 30, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a patient-centric healthcare company focused on developing innovative therapies for Testosterone Deficiency, is pleased to announce the submission of its New Drug Submission (NDS) for KYZATREX® (testosterone undecanoate) CIII capsules to Health Canada for approval. This submission marks the company’s first international filing, with an anticipated approval date in Q2 of 2025.
KYZATREX is an oral testosterone replacement therapy designed to treat adult men with low or no testosterone levels due to certain medical conditions. KYZATREX offers a convenient and effective alternative in the form of a softgel capsule, which is absorbed primarily via the lymphatic system, thereby avoiding liver toxicity. If approved, KYZATREX could become the only oral testosterone option available in Canada. KYZATREX received U.S. FDA approval in July 2022.
“We are excited by this first international filing and look forward to helping more patients by broadening the availability of oral testosterone. Our goal is to provide men worldwide with access to effective, convenient treatment options for testosterone deficiency,” said Nita Nimmons, Director of Quality and Regulatory at Marius Pharmaceuticals. “Testosterone is a critical metabolic hormone that is crucial for many functions in the body. We hope that by increasing access to KYZATREX, we can become part of a solution to what has become a worldwide men’s health crisis.”
KYZATREX Clinical Trial Highlights:
The Impact of Low Testosterone on Men’s Health in Canada
Testosterone deficiency, or hypogonadism, is a chronic condition that affects over twenty million men in the United States and millions more worldwide.2,3 In Canada, the prevalence of testosterone deficiency is significant. Approximately 25% of Canadian men aged 40–62 years are estimated to have testosterone deficiency, with rates increasing with age.4 Moreover, the Canadian Men’s Health Foundation reports that nearly 50% of Canadian men aged 40–88 experience erectile dysfunction, a condition often associated with low testosterone levels.5
Low testosterone is commonly associated with sexual health, but its impacts extend far beyond. It has significant effects on physical, cardiovascular, cognitive, and metabolic health, including obesity, type 2 diabetes, depression, osteoporosis, inflammation, and muscle wasting (sarcopenia). Addressing this condition effectively is crucial to improving the overall health and well-being of men, and reducing the broader healthcare burden.
“Marius anticipates that Canadian healthcare will mirror the advancements seen in American healthcare, particularly in the realms of health, wellness, and telehealth,” said Amit Shah, the COO of Marius Pharmaceuticals. “The introduction of KYZATREX into the Canadian market is poised to support this progressive vision, offering a comprehensive approach to addressing testosterone deficiency and enhancing the overall health of men.”
F**king A!
Looks like they may have beat out Verity Pharmaceuticals oral Tlando for dibs on the Canadian market!
RALEIGH, N.C., July 30, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a patient-centric healthcare company focused on developing innovative therapies for Testosterone Deficiency, is pleased to announce the submission of its New Drug Submission (NDS) for KYZATREX® (testosterone undecanoate) CIII capsules to Health Canada for approval. This submission marks the company’s first international filing, with an anticipated approval date in Q2 of 2025.
KYZATREX is an oral testosterone replacement therapy designed to treat adult men with low or no testosterone levels due to certain medical conditions. KYZATREX offers a convenient and effective alternative in the form of a softgel capsule, which is absorbed primarily via the lymphatic system, thereby avoiding liver toxicity. If approved, KYZATREX could become the only oral testosterone option available in Canada. KYZATREX received U.S. FDA approval in July 2022.
“We are excited by this first international filing and look forward to helping more patients by broadening the availability of oral testosterone. Our goal is to provide men worldwide with access to effective, convenient treatment options for testosterone deficiency,” said Nita Nimmons, Director of Quality and Regulatory at Marius Pharmaceuticals. “Testosterone is a critical metabolic hormone that is crucial for many functions in the body. We hope that by increasing access to KYZATREX, we can become part of a solution to what has become a worldwide men’s health crisis.”
KYZATREX Clinical Trial Highlights:
- Up to 96% Efficacy1
In a six-month clinical trial of 139 men with low testosterone, 88% of 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 90.1
- Safety Profile
Only one drug-related adverse event was observed in more than 2% of study participants: hypertension (2.6%).1
- 2x Increase in Free Testosterone1
Mean Free Testosterone levels increased from 7.0 ng/dL to 14.1 ng/dL after 90 days of treatment.
The Impact of Low Testosterone on Men’s Health in Canada
Testosterone deficiency, or hypogonadism, is a chronic condition that affects over twenty million men in the United States and millions more worldwide.2,3 In Canada, the prevalence of testosterone deficiency is significant. Approximately 25% of Canadian men aged 40–62 years are estimated to have testosterone deficiency, with rates increasing with age.4 Moreover, the Canadian Men’s Health Foundation reports that nearly 50% of Canadian men aged 40–88 experience erectile dysfunction, a condition often associated with low testosterone levels.5
Low testosterone is commonly associated with sexual health, but its impacts extend far beyond. It has significant effects on physical, cardiovascular, cognitive, and metabolic health, including obesity, type 2 diabetes, depression, osteoporosis, inflammation, and muscle wasting (sarcopenia). Addressing this condition effectively is crucial to improving the overall health and well-being of men, and reducing the broader healthcare burden.
“Marius anticipates that Canadian healthcare will mirror the advancements seen in American healthcare, particularly in the realms of health, wellness, and telehealth,” said Amit Shah, the COO of Marius Pharmaceuticals. “The introduction of KYZATREX into the Canadian market is poised to support this progressive vision, offering a comprehensive approach to addressing testosterone deficiency and enhancing the overall health of men.”
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) 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 quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive 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.
