Breakthrough Erectile Dysfunction Gel Receives FDA Clearance for Over-the-Counter Sale

A “breakthrough” gel that can induce an erection within 10 minutes is now available for purchase in the United States – and it doesn’t require a prescription.

The Food and Drug Administration (FDA) this week approved the drug called Eroxon, clearing the way for pharmacy stocking.

It is the first erectile dysfunction treatment gel approved for over-the-counter sale in the United States. Stocks are expected to be available by 2025.

The gel is an alternative to standard treatments like Viagra, which come in tablet form and can last up to an hour to take effect.

The Eroxon pictured above is applied to the glans 15 seconds before sex and can induce an erection within 10 minutes. It’s already available in the UK and US, where it’s sold in boxes of four tubes each

The gel is already available in single-dose tubes in the UK and Belgium, where it’s priced at around $7.80 per tube.

Men using the gel are advised to rub it on the glans about 15 seconds before sex.

An erection is induced about ten minutes later, the developers say, and 63 percent of users subsequently have “successful” sex.

The drug relaxes the smooth muscles in the shaft of the penis, which allows blood to flow to the region and induce an erection.

In phase III clinical trials, about 63 percent of the men who used the gel said they noticed an improvement after 12 weeks. 250 men were involved in the process.

In a second phase 3 study involving 47 men, a total of 61 percent also said they saw a significant change within 24 weeks.

Reported side effects were usually mild and went away on their own, the studies found.

These included mild to moderate pain or discomfort in the penis, and a warm, tingling, or burning sensation in the penis.

James Barder, CEO of Futura Medical in the UK, which invented the gel, called the approval a “major milestone”.

He said, “The US FDA’s approval of the first clinically proven, topical erectile dysfunction treatment gel available without a doctor’s prescription in the United States is a major milestone for Futura.”

“The FDA has set very high standards when evaluating efficacy and safety [medical devices].

“I am pleased that we have fulfilled this requirement.” [the gel’s] Submission of 22 clinical… studies and proficiency tests rigorously reviewed and accepted by the FDA.’

When 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 that will launch Eroxon in the US.”

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

Approximately 30 million Americans suffer from erectile dysfunction, mostly between the ages of 40 and 70, a condition that has become increasingly prevalent in recent decades.

Experts believe that an increase in poor diet, a sedentary lifestyle and heightened awareness of erectile dysfunction could be responsible for the higher rates.