Menopause Matters Forum

Menopause Discussion => All things menopause => Topic started by: Hurdity on April 27, 2017, 12:05:23 PM

Title: New soft-shell estradiol capsule for VA being developed in US
Post by: Hurdity on April 27, 2017, 12:05:23 PM

I thought members might be interested in this.

There is a new product that has been developed in US for treatment of VA and associated symptoms which has been trialled and is now going through the applications process with the FDA there.

It is a new estradiol soft gel capsule which releases local oestrogen without the need for an applicator so is inserted directly into the vagina. From what I can gather at a quick glance at the paper reporting the trial results, it is at least as effective as current preparations and maybe quicker acting,  and has negligible to very low systemic absorption – apparently even lower than Vagifem, and as expected hardly any side effects. It was tested at 3 concentrations including 10 and 25 mcg  - like vagifem.

At the moment the product is known as TX-004HR – but looking at the FDA entry it seems to have been given the catchy name of “Yuvvexy” !! I wonder if it will be approved eventually and if so, eventually approved herein UK too? Does sound like a promising additional treatment....

You can read about the trial here:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5367497/

and the current status of the application ( doesn't tell you much though!) here:
https://markets.ft.com/data/announce/full'dockey=600-201704190645BIZWIRE_USPRX____BW5433-1

Hurdity x

Title: Re: New soft-shell estradiol capsule for VA being developed in US
Post by: Tempest on April 27, 2017, 12:21:10 PM

That's fabulous news, Hurdity! Thanks for sharing. :thankyou:

Wow......that name, though!!! ;D

It's great that it has less systemic absorption as women who are contraindicated for systemic estrogen due to estrogen receptive cancer may be able to get away with this under their specialist's supervision. I hope it gets pushed through quickly and arrives on these shores soon. xxxx

Title: Re: New soft-shell estradiol capsule for VA being developed in US
Post by: Maryjane on April 27, 2017, 12:49:33 PM

Thank you Hurdity. 😊💐x

Title: Re: New soft-shell estradiol capsule for VA being developed in US
Post by: MicheleMaBelle on April 27, 2017, 01:19:57 PM

Thanks Hurdity- it should ironically be called YukSexy!

Title: Re: New soft-shell estradiol capsule for VA being developed in US
Post by: Tempest on April 27, 2017, 01:27:48 PM

 :rofl:

Title: Re: New soft-shell estradiol capsule for VA being developed in US
Post by: Lanzalover on April 27, 2017, 03:34:01 PM

Thanks Hurdity sounds promising.

Lanzalover x

Title: Re: New soft-shell estradiol capsule for VA being developed in US
Post by: ancient runner on April 28, 2017, 11:01:34 AM

If it has even lower absorption I wonder if it might also be useful for those of us with particular VA problems who could use a higher dose locally? Wonderful news for people who can't use local oestrogen because of cancer risk too. Bring it on!