madman
Super Moderator
* However, he noted there is still hope for the industry as Marius is currently developing an oral testosterone treatment for women.
“Things are changing,” he said. “More and more people are recognizing this as a treatment, so there is a chance that it will be approved by the FDA soon.”
www.mmm-online.com
Medical experts say that boosting testosterone levels can improve menopause symptoms, but awareness of the treatment is still low.
Shalin Shah is CEO of Marius Pharmaceuticals, the company that creates the only FDA-approved oral testosterone treatment for men.
Shah pointed to a number of studies in the mid-2010s that linked the increase in testosterone levels in men with non-fatal myocardial infarction, where blood flow to a portion of the heart muscle is blocked.
“At that time, the FDA changed the labels on testosterone and added a cardiovascular risk warning,” he said.
Ultimately, this had an impact on the safety profile of testosterone. While studies around the hormone and its use in women were still being conducted, it wasn’t approved as a treatment option for this patient population.
However, the narrative around testosterone began to change in 2023.
That year, a New England Journal of Medicine study involving over 5,200 men found that testosterone replacement therapy does not increase the risk of major adverse cardiovascular events in men with low testosterone.
This was a win for those in the testosterone treatment space and led the FDA to remove the black box label for the treatment in February of this year.
Despite this development, Shah said there is still not much attention around the decision to remove the risk profile connected to testosterone.
“There’s a gap in the traditional media talking about the benefits of hormone therapy for the benefit of patients,” he said.
However, he noted there is still hope for the industry as Marius is currently developing an oral testosterone treatment for women.
“Things are changing,” he said. “More and more people are recognizing this as a treatment, so there is a chance that it will be approved by the FDA soon.”
“Things are changing,” he said. “More and more people are recognizing this as a treatment, so there is a chance that it will be approved by the FDA soon.”
Menopause and testosterone: Treatment option or justified taboo?
Medical experts say that boosting testosterone levels can improve menopause symptoms, but awareness of the treatment is still low.
www.mmm-online.com
Medical experts say that boosting testosterone levels can improve menopause symptoms, but awareness of the treatment is still low.
Where is the FDA approval?
While experts say there is no singular reason that testosterone has not been approved by the FDA for women’s use, discourse around its safety profile in men has been cited as a potential factor.Shalin Shah is CEO of Marius Pharmaceuticals, the company that creates the only FDA-approved oral testosterone treatment for men.
Shah pointed to a number of studies in the mid-2010s that linked the increase in testosterone levels in men with non-fatal myocardial infarction, where blood flow to a portion of the heart muscle is blocked.
“At that time, the FDA changed the labels on testosterone and added a cardiovascular risk warning,” he said.
Ultimately, this had an impact on the safety profile of testosterone. While studies around the hormone and its use in women were still being conducted, it wasn’t approved as a treatment option for this patient population.
However, the narrative around testosterone began to change in 2023.
That year, a New England Journal of Medicine study involving over 5,200 men found that testosterone replacement therapy does not increase the risk of major adverse cardiovascular events in men with low testosterone.
This was a win for those in the testosterone treatment space and led the FDA to remove the black box label for the treatment in February of this year.
Despite this development, Shah said there is still not much attention around the decision to remove the risk profile connected to testosterone.
“There’s a gap in the traditional media talking about the benefits of hormone therapy for the benefit of patients,” he said.
However, he noted there is still hope for the industry as Marius is currently developing an oral testosterone treatment for women.
“Things are changing,” he said. “More and more people are recognizing this as a treatment, so there is a chance that it will be approved by the FDA soon.”
