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The FDA authorized the gel Eroxon to be sold in the U.S. over the counter to treat erectile dysfunction. Willie B. Thomas/Getty Images
  • The FDA has allowed a new topical gel Eroxon to be sold over the counter to help treat erectile dysfunction.
  • The approval was for marketing Eroxon as an over-the-counter option, the first in the United States.
  • Eroxon is already available in parts of the United Kingdom and Europe, though a release timeline in the U.S. is unclear.

MED3000, a new gel sold as Eroxon, has been approved for marketing by the Food and Drug Administration (FDA) to treat erectile dysfunction.

Eroxon received a “de novo” classification by the FDA, which means it can be marketed as an over-the-counter (OTC) option for those with erectile dysfunction, a first in the market.

According to the National Institutes of Health (NIH), around 30 million Americans have erectile dysfunction.

Dr. Amy Pearlman, a board certified urologist at Prime Institute in Fort Lauderdale, FL, told Healthline the FDA’s recent approval of Eroxon is an exciting development for those who are looking for more treatment options for erectile dysfunction.

“I’m pumped… When it comes to erectile dysfunction therapies, we have a lot of them. We have a lot of tools in our toolbox, which is great,” Dr. Pearlman said.

“But they all have their pros and cons — and so this option for an OTC makes it accessible and one that’s applied topically just adds another tool to our armamentarium.”

The de novo classification does mean that the FDA understands the product to be a new development.

But just because Eroxon has received marketing approval in the U.S. does not mean that it is currently available.

The company has advertised launches in various markets for “2023 and beyond” but it is unclear what timeline the company is on for an American release.

MED3000 is already available in Belgium and the United Kingdom after its regulatory approval there in April 2021.

One of the main selling points that Futura Medical — the British owners of MED3000 — have keyed on is its over-the-counter availability versus prescription-only options.

It’s important to note that the gel is what is known as a medical device as opposed to being classed as a pharmaceutical.

In other words, it’s trying to create a physical stimulation, in this case via the nerves in the penis, rather than a chemical one.

According to data provided by the company, the trial aimed at garnering FDA approval saw 60% of participants have an erection within 10 minutes.

That study also found that very few participants had adverse side effects, with the most common being a headache.

Despite the promising results, Dr. David Shusterman of NY Urology said that people with erectile dysfunction should still see a physician to get to the underlying cause of the issue.

“I think most patients in my practice want to see a doctor first to identify if there’s a cause of the problem. Because one of the key things about erectile dysfunction is you really want to get down to the root of the problem and not just kind of put a Band-Aid on it with the medicine.”

Pearlman said that pill-based options for treating erectile dysfunction via a prescription may create a barrier for some.

“Think of heartburn,” Pearlman said. “Do we say that every person who experiences heartburn needs to see a gastroenterologist? No. So, I think [OTC Eroxon] allows more accessibility. And as long as it’s a safe option, and people understand how to use it and who’s a good candidate, I think it’s great.”

Erectile dysfunction is currently treated with prescription medications like Cialis or Viagra, or injection or surgical methods.

Pearlman said a suppository like MUSE can offer a pathway to treatment that patients might consider, given the prevalence of the condition.

Shusterman said he sees a benefit of Eroxon for those who don’t like to take treatments like pills orally, but that there are drawbacks to topical options that patients and practitioners should be aware of.

“Part of the problem is, when people are taking it on their skin, the absorption takes longer, and it may not absorb all the way, and their effects may not be as good… and it’s hard to control the dosage,” Shusterman said.

“There’s a lot of different variables that I think [mean that] although it’s a positive thing, I think it leads to a better overall discussion about, ‘Why are these meds under prescription, anyway?’”

Shusterman said that while he understands that efforts are underway to reduce barriers to therapies for erectile dysfunction, part of the reason a doctor’s visit can be valuable is to identify other health risks.

“I think that it does relate to identification of, say, low testosterone levels, identification of pre-diabetic condition, and other things that we can figure out about a patient when they start developing erectile dysfunction.”

Although the Eroxon gel is not yet available in the U.S., Pearlman agrees that those with erectile dysfunction should be aware of how ED can point to other conditions.

“It’s important that people know that heart disease is the number one risk factor for erectile dysfunction,” Pearlman said.

“Diabetes is number two. So it’s good for people to know: where does their blood pressure run? Have they been tested for diabetes? Do they have signs and symptoms of sleep apnea? Are they overweight? And really getting at the underlying causes that might cause their ED and that should prompt them to see a health care provider.”