Breakthrough erectile dysfunction gel that triggers erections in 10 MINUTES gets FDA green light to go over-the-counter for about $7 a tube
A ‘revolutionary’ gel that can trigger an erection in 10 minutes can now be bought in the US – and you don’t need a prescription to get it.
The Food and Drug Administration (FDA) approved the treatment – dubbed Eroxon – this week, paving the way for it to be stocked in pharmacies.
It becomes the first erectile dysfunction gel to be approved for over-the-counter sale in the United States, with stock expected to be available by 2025.
The gel is already on sale in single-dose tubes in the UK and Belgium, priced at around $7.80 per tube.
The gel is an alternative to standard treatments such as Viagra, which comes in pill form and can take up to an hour to kick in.
Eroxon, pictured above, is applied to the head of the penis 15 seconds before intercourse and can trigger an erection within 10 minutes. It is already available in the UK and the US where it is sold in boxes each containing four tubes.
Men who use the gel are told to rub it on the head of their penis about 15 seconds before sex.
An erection is triggered around 10 minutes later, according to the developers, with 63% of users saying they had successful or penetrative sex afterwards.
The drug works by relaxing the smooth muscles in the shaft of the penis, allowing blood to flow to the area and triggering an erection.
In phase three clinical trials, around 63% of men using the gel said they saw improvement after 12 weeks. The trial involved 250 men.
In a second phase three trial that included 47 men, a total of 61% also said they saw a significant change within 24 weeks.
Reported side effects were generally mild and went away on their own, according to studies.
They included mild to moderate pain or discomfort in the penis as well as a feeling of warmth, tingling or burning in the member.
James Barder, chief executive of Futura Medical in the UK, which invented the gel, announced the approval as a “significant milestone”.
He said: “The granting of marketing clearance by the US FDA as the first clinically proven topical gel for the treatment of erectile dysfunction in the US available without a medical prescription is a significant milestone for Futura. .
“The FDA has set a very high standard in evaluating the efficacy and safety of [medical devices].
“I am delighted that we have reached this standard with [the gel’s] submission of 22 clinical studies and performance tests that have been rigorously reviewed and accepted by the FDA.
Asked about pricing, a company spokesperson told CNN: “We don’t have specific pricing details yet, as pricing will ultimately be determined by the partner who launches Eroxon in the United States.
A four-pack of Eroxon currently costs around $31.22 (£24.99) in the UK, where it is available.
About 30 million Americans suffer from erectile dysfunction, mostly between the ages of 40 and 70, a condition that has become more prevalent in recent decades.
Experts suggest that the rise in poor diets, sedentary lifestyles and increased awareness of erectile dysfunction may be behind the higher rates.
