How to Overcome Erectile Dysfunction Without Viagra > Eroxon?

ED, or erectile dysfunction, has become a commonly recognized term, along with Viagra and Cialis, the drugs used to treat it. But is it possible to overcome erectile dysfunction naturally? What about the latest treatment called Eroxon? Please pardon the name. We could not make a name like that up. The British company (Futura Medical) that developed this drug was obviously creating a play on words.

What is Eroxon?

Let’s start with the basics. Eroxon is not considered a drug. Here is how the company describes its product:

“Eroxon® is a fast-acting treatment gel for erectile dysfunction (ED) that can be applied immediately before sexual activity and is clinically proven to help you get an erection within 10 minutes. As the first-and-only ED gel, Eroxon® offers men and their partners results without the side effects of oral medicines or the inconvenience of getting a prescription.”

We have been relying on The Medical Letter on Drugs and Therapeutics for independent and objective evaluation of medications for many decades. Here is how the November 11, 2024 issue describes Eroxon:

“The FDA has authorized over-the-counter (OTC) sale of a nonmedicated alcohol-based gel (Eroxon – Futura) for treatment of erectile dysfunction (ED) in males ≥22 years old. Eroxon is the only FDA-approved OTC and topical treatment for erectile dysfunction. It is OTC and available in the UK and the EU.

It is now available in the US too.

So…we have  descriptions that call Eroxon a “treatment” and a “nonmedicated alcohol-based gel.” It has not been “approved” as a drug. Instead it has been “authorized,” “granted” or “FDA-cleared.” What does that mean?

I asked the Food and Drug Administration what “De Novo request (21 CFR Part 801 Subpart C) means when it comes to “clearing” a product like Eroxon. Turns out the FDA describes this kind of request for treatment this way:

“A De Novo request is a process used by the FDA to classify new medical devices as class I or class II instead of class III. The De Novo process is intended to be an efficient way to ensure that devices are classified appropriately to protect public health.”

I wanted to understand how a topical application (containing ethanol, propylene glycol, glycerol, carbomer, and potassium hydroxide) could be defined as a “device.”

The FDA responded with challenging bureaucratic jargon:

(The CDRH stands for Center for Devices and Radiological Health)

“Background

“CDRH regulates medical devices in accordance with the definition of a medical device. If a product is determined to be a medical device, then this device is classified into Class I, II, or III, based on the level of risk associated with the medical device. This is largely based on precedent: once the FDA has classified a medical device type, all medical device types that fall into this category are required to comply with the requirements of this Class.

“In some cases, CDRH is presented with a new type of medical device that the Agency has not regulated before. For new types of medical devices, CDRH automatically classified this new device type into Class III, which is the highest level of classification. In addition, CDRH has a regulatory tool, which is informally called ‘the De Novo.’ This allows the Center to downclassify the new medical device type from Class III to either Class I or II, and apply a lower, and least burdensome regulatory approach to this device type.

“This Case

“Now, specific to the facts of this case, this product involves a medical device that was regulated by CDRH through the De Novo process. In doing so, the device type was granted a De Novo under DEN220078, and as a result, CDRH created a new regulatory classification under 21 Code of Federal Regulation 876.5021. When CDRH grants a De Novo, the Center generates several publicly available documents that help to describe the Center’s regulatory decision-making behind this decision. This includes:

• Classification Order: This is the letter that the applicant received, which indicates that their device submission reached a final decision. In this case, the De Novo was granted. In this classification order, the Center defines the generic type of device that was classified as a result of this De Novo, the risks to health the associated mitigation measures, and special controls.
• Decision Summary: This document provides the FDA’s comprehensive summary of the application, which includes a summary of performance testing, including both non-clinical and clinical testing, and other information.

“It appears that the question is why a topical product might be considered to be a medical device. In reading this decision summary, it appears that the scope of this medical product is limited to non-medicated topical formulations (in this case, this is listed specifically as “non-medicated, hydro-alcoholic gel formulation”); and in addition, it appears that the primary mechanism of action is intended to induce a temperature change that stimulates the nerve endings. In the course of the review of the medical device, it was first confirmed that this product meets the definition of a medical device. After this decision is confirmed, then the Center proceeds with the technical regulatory review of this medical device application, and which led to the De Novo. which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

“As for authorize vs approved terminology, only PMA devices are ‘approved’d. De Novo devices are ‘granted’ and 510(k) are ‘cleared’.”

If you managed to make any sense out of that, you get 5 gold stars. It took me several readings to figure any of it out.

Does Eroxon Work?

Truthfully, I am in no position to offer an opinion. We would love feedback from people who have tried it!

The Medical Letter describes the MECHANISM OF ACTION this way:

“Eroxon gel contains, ethanol, propylene glycol, glycerol, carbomer, and potassium hydroxide. According to the manufacturer, application of the product to the glans of the penis produces successive cooling and warming sensations, which stimulate neural transmission and increase blood flow.”

The Medical Letter goes on to describe erectile function improvement after three months with Eroxon:

“…at 12 weeks was 63% overall, 61% in those with mild ED, 59% in those with moderate ED, and 80% in those with severe ED…An erection occurred within  10 minutes of application in 60% of uses.”

The Medical Letter concluded that Eroxon was fast on, had relatively few side effects and unlike oral ED drugs, doesn’t interact with other medications.

Sounds good, but I am having a devil of a time understanding why or how successive warming and cooling sensations could feel great. But then again, I have not tried Eroxon.

We would love to get comments from people who have! You can comment at the bottom of this article.

Men Can Overcome Erectile Dysfunction with Exercise:

A study from Portugal suggests that men who have erectile difficulties may be able to improve their symptom with exercise. The research was a meta-analysis of seven studies including 500 men between 43 and 69 years old. These were randomized controlled trials that had some men doing regular aerobic exercise while others were not encouraged to increase their activity.

Men who exercised improved their score on the International Index of Erectile Function. This included men with heart disease, increased cardiovascular risk or those who had undergone prostatectomy.

The improvement seen with exercise was equivalent to that seen with medication. Doctors who treat men with ED should recommend exercise to help overcome erectile dysfunction. Side effects of exercise? Usually men will feel better and get stronger. Exercise can also improve heart health and psychological well-being.

British Journal of Sports Medicine, online October 5, 2016 

Should You Try Exercise to Overcome Erectile Dysfunction?

Men with ED should ask their doctors to check their heart health. This sexual problem can be a red flag for heart trouble (American Journal of Cardiology, online Sept. 13, 2016). Men with diabetes are also more prone to erectile dysfunction (Current Diabetes Reports, Dec., 2016). Of course, any man with heart problems should get the doctor’s OK before starting an exercise program. Exercise might also be an effective treatment for premature ejaculation as well as helping a man overcome erectile dysfunction (Journal of Sexual Medicine, Oct., 2016).

If you have tried Eroxon, please describe your experience the comment section below.