published on July 10, 2024 in Front Page News

FDA approves Eroxon as a treatment for erectile dysfunction

Eroxon, a topical gel intended to treat erectile dysfunction, may soon be available in the United States.

The Food and Drug Administration authorized the marketing of the product as a medical device on Friday. Eroxon, a first-of-its-kind treatment for erectile dysfunction, will not require a prescription.

Eroxon isn’t a drug; the FDA calls it a “non-medicated hydro-alcoholic gel.” Futura Medical, a U.K.-based company that manufactures Eroxon, markets the topical treatment as a “fast-acting gel” that helps men “get an erection within 10 minutes.”

When a pea-sized amount of Eroxon is applied to the head of the penis, the gel evaporates, rapidly cooling the skin before a gradual warming effect. Futura Medical pitches the application of the gel as “a natural part of foreplay” that will ultimately lead to an erection.

More than 60 percent of the patients who used the gel in one clinical trial experienced a “clinically meaningful improvement” in their erectile dysfunction, Futura Medical says. The company, however, has not released the full results of its clinical trials.

Some experts are skeptical of the company’s claims.

“As a scientist, what I would look for is: ‘Is there any statistical evidence that this is better than a placebo?’ And I haven’t found a paper on that yet that’s been published,” said Stan Honig, professor of urology and the division chief of sexual and reproductive health at Yale School of Medicine.

There isn’t enough data for sexual medicine specialists to start recommending Eroxon to patients, Honig said.

Pills such as Cialis and Viagra, injections and surgery are the most common treatments currently available for erectile dysfunction.

The FDA said it would make public the summary of its decision-making process to grant marketing authorization to Eroxon as a medical device — under the De Novo classification pathway — but did not say when. The agency’s De Novo summary details the scientific evidence used to grant such requests.

Another option for erectile dysfunction treatment

About 30 million men in the United States have some form of erectile dysfunction — trouble getting or sustaining an erection. The condition is more common among older adults, though it’s not a normal part of aging; erectile dysfunction can be a sign of other serious health problems such as heart disease, experts say.

Arthur L. Burnett, principal investigator of a clinical trial for Eroxon in the United States, said the over-the-counter topical gel is “another item on the menu” for millions of men to treat erectile dysfunction.

“This is an alternative treatment in a novel direction that we think has efficacy,” said Burnett, a professor of urology and the director of the Basic Science Laboratory in Neuro-Urology at Johns Hopkins University. “It’s an intriguing new therapy, and I think it just expands our range of treatment options.”

In one clinical trial, Futura Medical recruited 96 men to take either Eroxon or tadalafil, the active ingredient in Cialis, for 24 weeks to treat erectile dysfunction. The full results of the clinical trial haven’t been published in a medical journal; a spokesperson for Futura Medical said the company has not released the data “due to competitor reasons.”

In a statement published last year, the company, however, said that Eroxon significantly improved “erectile function” compared with the pretreatment period. By the end of the trial, 85 percent of the participants using Eroxon said in a questionnaire that they felt sex could be spontaneous at least sometimes after using the product. Eroxon acted “demonstrably faster” than tadalafil in the clinical trial; however, Futura Medical also said “overall tadalafil showed a greater improvement in erectile function.”

Burnett said “we don’t fully understand” the true mechanism of the treatment, but the gel appears to generate enough sensitivity in the nerves on the penis to lead to an erection.

When Eroxon is applied, the temperature on the skin of the penis drops 10 degrees Celsius (18 degrees Fahrenheit) in about 60 seconds, said David Ralph, a urologist at University College London, who is a co-author of one of the clinical trials funded by Futura Medical.

The participants using Eroxon didn’t report any serious adverse side effects, the company said. There were some reports of headaches, which also is a known side effect for other erectile dysfunction treatments.

On Eroxon’s website, the company states “it is unlikely” the topical gel will cause adverse side effects for partners. The clinical trials only recruited men in heterosexual relationships.

Pills are most popular treatment for erectile dysfunction

There are three main types of treatment for erectile dysfunction — pills, injections and surgery, said Seth D. Cohen, director of the Sexual Dysfunction Program at NYU Langone Health.

Pills such as sildenafil (Viagra) and tadalafil (Cialis) work by “a series of events in the penis that will increase or maintain blood flow to the penis,” Honig said. “Penile injections work by directly relaxing the muscle of the penis to increase blood flow.”

Eroxon stimulates the skin of the most sensitive part of the penis, intending to work from the outside in. The gel could be a faster, easier solution when compared with pills that need to be taken at least 30 minutes before sex, Futura Medical says.

Pills are the most popular treatment for erectile dysfunction, but there are some side effects, including headaches and runny noses, as the drugs dilate the blood vessels “all over your body,” Cohen said. And, in some cases, people already taking medication for chest pain or certain heart conditions can’t take pills for erectile dysfunction because the combination can cause an unsafe drop in blood pressure.

Cohen said he’s excited to see potential new options for erectile dysfunction that are easier for people to access. Companies, though, have been trying, for years, to create salves or balms to help men get erections. Cohen said he doubts that an over-the-counter topical gel will be effective in all but the most mild cases of erectile dysfunction.

“How do you penetrate all the layers of the penis to get down deep to those arteries with just a cream or a spray?” Cohen said. “I just can’t see it helping men with moderate to severe disease because, in most cases, you’re talking about severely damaged arteries.”

Mixed reviews of Eroxon

Futura Medical has not said when the topical gel will be available over the counter in the United States or what it will cost, according to a spokesperson for the company. Eroxon, which launched in the United Kingdom in April, is available there over the counter for 24.99 pounds (about $32) for four doses. It also is available in Belgium.

The British response to Eroxon has been mixed. Reviews range from “Rubbish” to “Super,” according to write-ups by shoppers on Boots, a major health retailer in the United Kingdom.

Eroxon may “offer some value, and if these results can be replicated, then I think this is something that we, as a field, could embrace for the right patient,” said Scott Lundy, a urologist in the Glickman Urological and Kidney Institute at Cleveland Clinic. “But it does not replace the medications like tadalafil, which have a much more robust improvement in erection function, according to the data.”

Even if you seek out over-the-counter solutions to erectile dysfunction, urologists say you should still talk to your physician about the issues you’re experiencing, as erectile dysfunction may be a sign of a broader concern such as heart disease.

“Sometimes these are harbingers of other disease states,” Cohen said. “It’s reasonable to believe if the arteries in your penis are not working well, the arteries around your heart may not be working well.”

correction

An earlier version of this article incorrectly said the temperature on the skin of the penis drops 50 degrees Fahrenheit when Eroxon is applied. It drops 18 degrees Fahrenheit. The article has been corrected.

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