- The FDA has allowed a new topical gel to be sold over the counter (OTC) as an aid for those with erectile dysfunction (ED).
- The approval was for marketing as an OTC option, the first in the United States.
- The product is already available in parts of the United Kingdom and Europe, though a release timeline in the U.S. is unclear.
A new product intended to treat erectile dysfunction, MED3000, has been approved for marketing by the U.S. Food and Drug Administration (FDA). The gel, which is marketed as Eroxon, received a “de novo” classification by the FDA and can now be marketed as an over-the-counter (OTC) option, a first in the market.
Dr. Amy Pearlman (MD), a board-certified urologist at Prime Institute in Fort Lauderdale, Florida, says this is an exciting development for those who are looking for more options.
“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. 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 means that the FDA understands the product to be a new development, although MED3000 is already available in Belgium and the United Kingdom after its regulatory approval there in April 2021. In data provided by the company, the trial aimed at garnering FDA approval saw 60% of participants have an erection within ten 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 (MD) of NY Urology says 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.”
What are the treatments available?
One of the main selling points that Futura Medical—the British owners of this medication—have keyed on is its availability versus a prescription-only option like Cialis or Viagra. Pearlman says that getting these pill-based options via a prescription creates a barrier because it’s not an ask that is always made of those with other common conditions.
“Think of heartburn. Do we say that every person who experiences heartburn needs to see a gastroenterologist? No…So, I think it 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.”
She also points to injection and surgical options—as well as a suppository like MUSE— as pathways to treatment that patients can also consider, given the prevalence of erectile dysfunction. According to the National Institutes of Health (NIH), upwards of 30 million Americans have erectile dysfunction. 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.
Shusterman adds 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.”
Shusterman says that he sees a benefit 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. 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?’”
Erectile dysfunction as an indicator of your health
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. Regardless of the gel’s status, 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. 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.”
FDA OKs New Gel Eroxon to Treat Erectile Dysfunction
Source: Pinoy Lang Sakalam
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