MED3000 for ED: an update

[KenJ1947]

With our FDA involved, we might see it in December 2025 ...

[Flavio]

With our FDA involved, we might see it in December 2025 ...

I know very little about regulatory procedures but it seems that all three phases have been completed in the case of MED3000 and now they want approval for making this OTC. I may be wrong, though.

The execs on the videos specifically mentioned the year 2021, let's wait and see. Fingers crossed!

[Leebert]

Went to there site and they said they hope to have approval either later this year or first part of next year. If your tri mix is failing I would assume that will also or not?

[Hunchback]

If your tri mix is failing I would assume that will also or not?

Given how little information is available, i don't think anyone can answer that before trying. My immediate thought was the same as yours, but who knows how exactly it works and what ingredients they are using.
The fact that it's gonna be "over the counter" worries me the most. Considering that prescription, "serious", drugs like EDEX and all the pills don't always work all that well, i wonder how something that's supposedly as simple as a Doliprane can work in a similar or better way.

There was a lot of hype about that other gel, Vitaros, and in my experience (and i believe everyone on this forum that's tried it) and according to my uro, it was a complete fail. Absolutely 0 effect, it's even off the European market because of how completely bullshit it was. AND it took a prescription to buy.

So dunno, as i said we can always hope. IF this thing actually works it's gonna be revolutionary. I just wouldn't hold my breath about it

[Simbarn]

I tend to agree with you Hunchback. I am trying to understand the science behind this, but it is so vague. They are suggesting it works directly by stimulating endothelial and neuronal NO, via nerve terminals in just the glans from what I could understand.
Does anyone know of any studies which demonstrate the processes involved here?

[Flavio]

ED is a 5 billion dollar market and yes, I believe there were cases of companies in the past that announced new ED treatments just to soar stock value. It seems, however, that MED3000 has already passed phase 3 and these guys are extremely optmistic.

I'm not sure if it was Vitaros but I once tried an alprostadil gel and the efficacy was zero. Hopefully, this one will do much better.

[Simbarn]

"MED3000 has a unique evaporative mode of action which the Company believes stimulates nerve endings in the glans penis to cause an erection."
This is from the Futura medical website.
For many men, it is not getting an erection that is a problem, it is maintaining one. Once this evaporative process has ended does the supposed enhancement of the NO pathway which they say it stimulates, cease?
Once the gel is removed or diluted by a lubricant or by insertion into the vagina or anus or by oral sex does this "evaporative process" stop or become subdued?
For a drug to work it needs to be absorbed into the structures it will affect. So I am having trouble understanding how the above mentioned process could have an effect for a reasonable amount of time if it relies on an evaporative process.

PDE5 inhibitors work by also enhancing the NO pathway, but further down the chain of events by inhibiting the degradation of CGMP. We clearly understand how this process works and why it enhances erectile function. The drugs are absorbed internally and have specific half-lives so they have a reasonable period of time to be effective.
I Have not been able to find how they “believe” this gel actually works in a clear scientific explanation?
Using words like “believe” is also a concern.

I am quite sure that this gel will not work nearly as effectively as Trimix injections. For the simple reason that these injections target both the pro-relaxation elements and the pro- constriction elements in the erectile tissues. Both of these elements change as we age and this is one reason why PDE5 inhibitors stop being effective and the more potent vasodilators and adrenergic blockers are required to have good effect locally.

[Flavio]

"MED3000 has a unique evaporative mode of action which the Company believes stimulates nerve endings in the glans penis to cause an erection."
This is from the Futura medical website.
[...]

Thank you for your comment, Simbarn.

What exactly is an evaporative process?

I know nothing about regulatory procedures but it's not surprising that there is still very little information on this. It is still too early, the treatment is not available yet and they probably don't want to give away their secrets.

[Flavio]

Latest news from Futura Medical (October 2020):

https://www.medicalplasticsnews.com/mpn ... r-med3000/

According to this article, the EU approval process continues to progress well.

In the United States, they speak of a 'requested supplemental clinical trial', I have no idea what that is.

[Simbarn]

Latest news from Futura Medical (October 2020):

https://www.medicalplasticsnews.com/mpn ... r-med3000/

According to this article, the EU approval process continues to progress well.

In the United States, they speak of a 'requested supplemental clinical trial', I have no idea what that is.

Sounds like they are not completely satisfied with the results from the clinical trials already submitted and they have requested a further trial to be completed. I have not read what they said so perhaps that states what further evidence is required from that trial or what was lacking in the previous ones.