What is Eroxon?

Eroxon is a topical gel that may be applied to the head of the penis immediately before sexual intercourse. Studies show that 65% of men who used it achieved an erection within 10 minutes and maintained it long enough to have sex.

Eroxon was approved on 13 June 2023 under the De Novo medical devices classification. It does not require a prescription from a doctor, making it the first approved OTC treatment for erectile dysfunction (ED) in the United States.

How do you use Eroxon?

Eroxon is supplied in single-use tubes. The contents of the tube are rubbed onto the head of the penis for 15 seconds immediately before sexual intercourse.

How does Eroxon work?

Eroxon contains a combination of volatile solvents which when applied to the head of the penis evaporate off it rapidly, stimulating nerve sensors located in the glans penis, through an initial cooling effect, then a recovery warming effect. This temperature, touch, and pressure effect results in the natural release of nitric oxide, which activates the relaxation of the corporal cavernosal smooth muscle tissue inside the penis, causing increased blood flow and the hardening and expansion of the penis into an erection.

Eroxon is only for use by men who have problems with ED, it is not recommended for those who do not have problems with ED.

What are the side effects of Eroxon?

Eroxon is well tolerated with 3% of men reporting a headache, and 1% of men and 0.4% of their female partners reporting a “localized burning sensation”.

Where can you buy Eroxon?

Although Eroxon is now approved in the U.S. it is not yet available for sale here and it may not become available for purchase until 2025.

How much will it cost?

Pricing details for Eroxon are not yet available but in the United Kingdom, it costs the equivalent of U.S. $31.22 for a pack of 4 single dose tubes.

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What studies have been done on Eroxon?

U.S.-specific studies include a Human Factors study to achieve OTC classification that recruited 32 men and demonstrated that they were able to correctly self-diagnose ED and make appropriate decisions based on their health history and concurrent conditions, considering the warnings on the label and the product information.

A 24-week, at-home, randomized, unblinded study called FM71 was also conducted in 96 males which compared the effects of MED3000 (what Eroxon was called pre-approval) to those of tadalafil 5mg (the active ingredient of Cialis). Participants had either organic or psychological ED or a combination of both and were recruited from the United States (African Americans), Poland, Georgia, and Bulgaria. In summary, the results were statistically significant and showed:

• A 5.73 change in the Internationally recognized IIEF-EF score which exceeded the 4-unit difference agreed with the FDA and was defined as the minimal clinically important difference. This was the primary endpoint
• Clinical effectiveness in mild, moderate, and severe ED sufferers
• A rapid speed of onset with the onset of an erection within 10 minutes which was faster than the control (tadalafil). This was a secondary endpoint
• No serious adverse events were reported and safety and tolerability data were highly positive.

Is Eroxon approved in any other countries?

Eroxon has been approved in the European Union since April 2021 as a Class 2B medical device which allows it to be marketed without the need for a doctor’s prescription. It has also received the post-Brexit UKCA mark, allowing its ongoing marketing in Great Britain.

Who makes Eroxon?

Futura Medical.