Both women and men naturally produce the hormone testosterone and, although women have much lower levels than men, it is just as important to their sexual health. At menopause, levels of testosterone can fall in a similar way to other hormones, estrogen and progesterone. Reduced levels of all...
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The testosterone TEPI Patch will provide women with a product that is specifically formulated to deliver the appropriate dose. It will be a twice-weekly patch, which is similar to other HRT patch products that many women are familiar with.
Medherant has had a scientific advice meeting with MHRA and anticipates a short clinical development pathway prior to approval in the UK and then Europe and other countries. Data from a Phase I pharmacokinetic study is expected by the end of 2023.
Health Tech World sat down Medherant CEO John Burt to learn about TEPI Patch and its potential applications in women’s health and beyond.
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But while John has high hopes for these promising third-party applications, he’s confident that Medherant’s testosterone patch will be the first to reach the market.
He says:
“I always say that we’re pushing at open doors.
“There’s clear payer recognition of the need for testosterone patches as evidenced by the NICE guidelines.
“There’s clear clinician demand in terms of the clinical guidelines for testosterone use.
“We’ve consulted with MHRA, and we know what we need to do for development.
“And most of all, there are many, many women who are desperate for a testosterone patch.”
Some of these women could try the patch as soon as early autumn, should the clinical trial receive MHRA approval over the summer as expected.
That will then enable Medherant to move into definitive clinical trials in 2024.
John says:
“Supporting that will be the scale-up in manufacturing and expanding the program.
“We’re very excited about reaching that significant milestone and moving things forward.”
https://www.medherant.co.uk/news/medherant-transdermal-patch-development-collaboration-bayer Coventry, UK (25 March 2024): Medherant Limited (“Medherant”) announces that it has entered into a Development Collaboration Agreement with Bayer for the development of a transdermal patch product for...
https://www.medherant.co.uk/news/preliminary-results-clinical-study-medherant%E2%80%99s-testosterone-patch-post-menopausal-women 10 April 2024 (Coventry, UK). Medherant is pleased to announce the preliminary results of the Phase I study of its testosterone patch technology being conducted at...