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Breakthrough Erectile Dysfunction Gel Can Now Be Sold Over-The-Counter In US

June 15, 2023 by Deborah Bloomfield

A first-of-its-kind topical gel used to treat erectile dysfunction can now be sold over the counter in the US thanks to a recent authorization by the US Food and Drug Administration (FDA). Known as Eroxon, the gel is a clinically proven treatment for erectile dysfunction and gets to work within just 10 minutes.

The FDA announced earlier this week that Eroxon (referred to as MED3000) has been granted a “de novo” classification because it’s a totally new type of product. This authorization allows the drug to be legally marketed in the US as an over-the-counter treatment without the need for a prescription. 

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The drug is already approved for this in the UK and Belgium. In the UK, a four-pack of Eroxon costs around £24.99 (over $31). However, there’s no word yet on how much it will cost over the Atlantic. 

The single-dose tube works by increasing blood flow in the penis by stimulating nerve endings through “a unique physical cooling then warming e­ffect,” according to Futura Medical, the makers of the drug. 

Users simply apply the gel onto the head of the penis and massage it in for about 15 seconds. Within 10 minutes, the majority of users will achieve an erection, which the company says will be “hard enough for satisfactory sexual activity”.

By comparison, common drugs to treat erectile dysfunction like Cialis and Viagra require a doctor’s prescription in the US and typically take up to 30 minutes to kick in. 

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“FDA set a very high standard in evaluating the effectiveness and safety of De Novo Medical Devices. I am delighted that we met this standard with MED3000’s submission of 22 clinical, biocompatibility, human factors studies and performance bench tests which were rigorously reviewed and accepted by the FDA,” James Barder, Chief Executive Officer of Futura Medical, said in a statement.

Erectile dysfunction is a problem for up to 30 million people in the US, according to the CDC. Although often associated with older men, it can affect people of any age for a myriad of reasons, including high blood pressure, diabetes, depression or anxiety, and hormone problems. 

It’s also sometimes simply the result of stress, nerves, tiredness, or drinking too much alcohol. The odd incidence of erectile dysfunction is common and typically nothing to worry about. However, if you notice it becoming a recurring problem, it is worth visiting your doctor as it could be a sign of another health condition.

The content of this article is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of qualified health providers with questions you may have regarding medical conditions.  

Deborah Bloomfield
Deborah Bloomfield

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Source Link: Breakthrough Erectile Dysfunction Gel Can Now Be Sold Over-The-Counter In US

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