First testosterone patch for menopausal women

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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.


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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.”
 
Beyond Testosterone Book by Nelson Vergel

 
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