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Marius Pharmaceuticals Helps Drive FDA’s Landmark Testosterone Label Update, Removing Black Box Warning
RALEIGH, N.C., March 03, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, is pleased to announce that the U.S. Food and Drug Administration (FDA) has...
RALEIGH, N.C., March 03, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, is pleased to announce that the U.S. Food and Drug Administration (FDA) has implemented significant labeling changes for KYZATREX® (testosterone undecanoate) CIII capsules. This decision follows the conclusion of the TRAVERSE trial and comprehensive blood pressure monitoring studies, marking a pivotal advancement in testosterone replacement therapy (TRT).
In September 2024, Marius Pharmaceuticals proactively submitted a Prior Approval Supplement (PAS) to the FDA, advocating for the removal of the Black Box Warning associated with testosterone products. Based on the overwhelming large body of evidence through the last decade, this filing was driven by a commitment to ensuring that patients have access to safe and effective therapies without unwarranted concerns.
The TRAVERSE trial, a large-scale clinical study with over 5,000 patients, published in 2023, concluded that TRT does not increase the risk of adverse cardiovascular outcomes in men with hypogonadism. As a result, the FDA has officially removed the previous Boxed Warning related to cardiovascular risks from all testosterone product labels.
Since the initial concerns about cardiovascular (CV) risk led to label changes in 2014, extensive research has reaffirmed the safety and benefits of testosterone therapy. A global consensus has emerged on testosterone’s cardiovascular profile, supported by robust studies. Notably, an 83,000-patient study from the Veterans Affairs (VA) system concluded that men receiving TRT experienced cardiovascular benefits.1
The strength of these studies, combined with today’s FDA decision, shifts the conversation from "Is testosterone safe?" to "What are the full health benefits testosterone can provide?"
“The removal of the box warning and long anticipated scientific conclusion opens up access to tens of millions of patients globally that can benefit from adequate testosterone therapy,” said Himanshu H. Shah, Executive Chairman of Marius.
The FDA now requires that all testosterone products include product-specific information regarding potential increases in blood pressure. Warnings about elevated blood pressure will be added to products such as testosterone injections and gels, which previously lacked such information, ensuring comprehensive patient awareness.
“For years, patients have been unduly apprehensive about testosterone replacement therapy due to the Black Box Warning, leading many to avoid a treatment that could significantly improve their health,” said Shalin Shah, CEO of Marius. “With the removal of this warning, patients and providers can finally have an informed, evidence-based discussion about the true benefits and risks of TRT. This positive shift will also accelerate Marius Pharmaceuticals’ research into additional therapeutic uses of testosterone.”
