Breakthrough erectile dysfunction gel gets green light from FDA to be sold without prescription

A ‘breakthrough’ gel that can trigger an erection within 10 minutes can now be bought in the United States — and you don’t need a prescription to get it.

The Food and Drug Administration (FDA) signed off on the treatment — dubbed Eroxon — this week, clearing the way for it to be stocked in pharmacies.

It becomes the first gel for treating erectile dysfunction to be approved for sale over the counter in the US, with stocks set to be available by 2025.

The gel is an alternative to standard treatments such as Viagra, which come in pill form and can take up to an hour to kick in.

The gel is already for sale in single-dose tubes in the UK and Belgium, where it is priced at about $7.80 per tube.

Men who use the gel are told to rub it onto the head of their penis about 15 seconds before sex.

An erection is triggered about 10 minutes later, the developers say, with 63 percent of users saying they then had successful — or penetrative — sex.

The drug works by relaxing the smooth muscles in the shaft of the penis, allowing blood to flow into the region and triggering an erection.

In phase three clinical trials, some 63 percent of men using the gel said they saw an improvement after 12 weeks. The trial involved 250 men.

In a second phase three trial that included 47 men, a total of 61 percent also said they saw a meaningful change within 24 weeks.

Side effects reported were usually mild and went away on their own, the studies found.

They included mild to moderate pain or discomfort in the penis as well as a warm, tingling or burning sensation in the member. 

James Barder, the chief executive officer at Futura Medical in the UK which invented the gel, heralded the approval as a ‘huge milestone’.

He said: ‘The granting of marketing authorization by the US FDA as the first clinically proven, topical gel for the treatment of erectile dysfunction in the US available without a doctor’s prescription is a huge milestone for Futura.

‘The FDA set a very high standard in evaluating the effectiveness and safety of [medical devices].

‘I am delighted that we met this standard with [the gel’s] submission of 22 clinical… studies and performance bench tests which were rigorously reviewed and accepted by the FDA.’

Asked about pricing, a spokesman for the company told CNN: ‘We don’t have specific pricing details yet as the pricing will ultimately be determined by the partner who launches Eroxon in the US.

A four-pack of Eroxon currently costs about $31.22 (£24.99) in the UK, where it is available.

About 30million Americans suffer from erectile dysfunction, mostly in their 40s to 70s, a condition which has become more prevalent in recent decades.

Experts suggest that the rise of poor diets, sedentary lifestyles and increased awareness of erectile dysfunction may be behind the higher rates.