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First-of-its-kind erectile dysfunction gel gets FDA’s OK for over-the-counter marketing, company says

(CNN) — A first-of-its-kind topical gel for the treatment of erectile dysfunction, called Eroxon, has been authorized for over-the-counter marketing in the United States, according to pharmaceutical company Futura Medical, which developed the product.

The company announced Monday that the US Food and Drug Administration granted marketing authorization for the over-the-counter sale of the gel, which it says is the first topical erectile dysfunction treatment available without the need for a prescription.

The FDA confirmed Monday that Eroxon has been granted a “de novo” classification, a nod to the gel being a new type of product. The de novo decision was made Friday.

“FDA set a very high standard in evaluating the effectiveness and safety of De Novo Medical Devices. I am delighted that we met this standard,” James Barder, chief executive officer of Futura Medical, said in a news release Monday.

Eroxon is already available in Belgium and the United Kingdom.

In the UK, a four-pack of Eroxon costs about £24.99, a Futura Medical spokesperson said Monday. That’s equivalent to about $31.22 in the US.

“We don’t have specific pricing details yet as the pricing will ultimately be determined by the partner who launches Eroxon in the US,” the spokesperson wrote in an email. The timing of when Eroxon will be available on store shelves in the US also depends on that partner, but some financial analysts predict that the product could launch in 2025.

leaflet for the product notes that the gel comes in a single-dose tube and should be applied to the head of the penis for 15 seconds before sex. Marketing materials for the product claim that it can help users get an erection within 10 minutes of application.

The erection lasts long enough for successful sex in about 65% of people and should naturally subside, according to Eroxon’s website.

In the United States, erectile dysfunction affects about 30 million men. It happens when someone is unable to get or keep an erection firm enough for satisfactory sexual activity.

Many factors can cause or contribute to erectile dysfunction, including diseases such as type 2 diabetes, medications such as antidepressants, psychological factors such as anxiety or behaviors such as smoking, drinking too much alcohol, using illegal drugs or being overweight.