FDA cleared over the counter gel for erectile dysfunction

[Graham49]

Haleon Announces the Launch of Eroxon®, The First and FDA Cleared OTC Gel for Erectile Dysfunction, Available for U.S. Preorder Without a Prescription.

News release. Haleon. September 3, 2024. prnewswire.com/news-release....

[cesanon]

You're correct to focus on the heating and cooling mechanism, as this is key to how Eroxon works. Let me explain the mechanism of action in more detail:Initial Application:

A small amount of gel is applied to the glans (head) of the penis.

The gel contains a mixture of volatile and non-volatile components.

Rapid Cooling Phase:

Immediately after application, the volatile components in the gel begin to evaporate quickly.

This evaporation causes a rapid cooling effect on the skin of the penis.

The temperature drop can be quite significant, occurring within seconds of application.

Gradual Warming Phase:

Following the initial cooling, there's a gradual warming effect as the skin temperature returns to normal.

This warming phase occurs over several minutes.

Nerve Stimulation:

The rapid temperature change (cooling followed by warming) stimulates the nerve endings in the glans penis.

This stimulation creates a strong sensory signal.

Physiological Response:

The nerve stimulation triggers the release of nitric oxide in the penile tissue.

Nitric oxide is a key molecule in the erectile process.

Blood Flow Increase:

Nitric oxide causes the smooth muscle in the blood vessels of the penis to relax.

This relaxation leads to vasodilation (widening of blood vessels).

As a result, blood flow to the penis increases.

Erection:

The increased blood flow causes the erectile tissue to fill with blood.

This leads to the firming and enlargement of the penis, resulting in an erection.

The unique aspect of Eroxon is that it initiates this process through a physical action (temperature change) rather than a pharmacological one. This is why it's classified as a medical device rather than a drug. The rapid onset of action (around 10 minutes) is another distinguishing feature compared to oral medications for erectile dysfunction.

It's important to note that, like other erectile dysfunction treatments, sexual stimulation is still necessary for Eroxon to be effective. The gel essentially "primes" the physiological response, making it easier to achieve and maintain an erection with sexual stimulation.

[Tall_Allen]

Several men in my support group got it from England and tried it. It had no effect.

[RJAMSG]

if it doesn’t work for most of us, I’m curious if it might help blood circulation to that area.

[inter100]

I live in UK and have tried Eroxon a few times.It did nothing.A waste of money.Several of my friends have had the same experience .

[dhccpa in reply to inter100]

Uh-oh. Not sounding good here...

[j-o-h-n]

It works if you spread it up and down your shaft with your fist for a few minutes....while holding an old issue of Playboy magazine in your free hand.

Good Luck, Good Health and Good Humor.

j-o-h-n

[CAMPSOUPS in reply to j-o-h-n]

Kinda like holding $50 in one hand and shaft in the other. When your done you still have $50.

[j-o-h-n in reply to CAMPSOUPS]

And with very little interest.........

Good Luck, Good Health and Good Humor.

j-o-h-n

[cancerfox in reply to j-o-h-n]

But not with one of the newer issues. 🦊

[Graham49]

I had trouble finding any scholarly articles on this until I found out it used to be called MED3000.

JOURNAL ARTICLE

(314) MED3000, A CLINICALLY PROVEN, FAST-ACTING TOPICAL PRODUCT FOR ERECTILE DYSFUNCTION WITH THE PROSPECT OF BEING THE FIRST GLOBALLY AVAILABLE OTC TREATMENT FOR ED

Ralph Dr. David, Holland Tim, James Ken, On behalf of Futura Medical Developments Ltd

The Journal of Sexual Medicine, Volume 20, Issue Supplement_4, July 2023, qdad062.118, doi.org/10.1093/jsxmed/qdad...

Published: 06 July 2023

“Conclusions

MED3000 has been shown to deliver a clinically meaningful response and is fast-acting. It was also shown to be clinically effective in mild, moderate and severe ED. Results were generally consistent with a previously conducted clinical study used for European approval MED3000 was shown to have minimal adverse events. Its “drug-free” formula provides a further margin of safety with no propensity for adverse drug interactions. This profile makes it suitable for OTC use.

FDA filing for marketing authorisation as a De Novo medical device occured in October 2022.”

PD52-07 EFFICACY AND SAFETY OF MED3000, A NOVEL TOPICAL THERAPY FOR THE TREATMENT OF ERECTILE DYSFUNCTION

Wayne J. G. Hellstrom, Gerald B. Brock, Arthur L. Burnett,

Tim J. Holland and Ken W. James

doi.org/10.1097/01.JU.00010...

“Approximately 60% of patients using MED3000 achieved clinically meaningful improvements in IIEF-EF domain scores in each of the two studies. In addition, 60.1% and 44.9% achieved erections in <10 minutes in FM57 and FM71, respectively (Table 1). MED3000 was associated with low risk for either local or systemic adverse events (Table 1).”

[Yzinger]

Surprise, it is available on Amazon.

amazon.ca/Eroxon-Stimgel-Tr...