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

A ‘breakthrough’ gel that can produce an erection in 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) this week signed off on the treatment — called Eroxon — paving the way for pharmacies to be stocked.

It will be the first erectile dysfunction treatment gel approved for sale over the counter in the US, with supplies due to be available by 2025.

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

The gel is already on sale in single-use tubes in the UK and Belgium, where it costs around $7.80 per tube.

Men using the gel are told to rub it on 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 having “successful” sex.

The drug works by relaxing the smooth muscles in the shaft of the penis, which allows blood to flow into the area and cause an erection.

In phase three clinical trials, about 63 percent of men who used the gel said they saw an improvement after 12 weeks. The process involved 250 men.

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

The reported side effects were mostly mild and went away on their own, the studies showed.

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

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

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

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

“I am delighted that we have met this standard [the gel’s] submission of 22 clinical…study and performance bench tests that were thoroughly 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 launching Eroxon in the US.

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

About 30 million Americans suffer from erectile dysfunction, usually between the ages of 40 and 70, a condition that has become more common 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.