Home Men Health Topical Gel for Erectile Dysfunction Gets FDA Approval for Over-the-Counter Sale

Topical Gel for Erectile Dysfunction Gets FDA Approval for Over-the-Counter Sale

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Topical Gel for Erectile Dysfunction Gets FDA Approval for Over-the-Counter Sale

TUESDAY, June 13, 2023 (HealthDay News) — Men with erectile dysfunction will now have the choice of using a topical gel to treat the condition.

The U.S. Food and Drug Administration has approved over-the-counter marketing for the product, called Eroxon, as a first-of-its-kind medical product. The British pharmaceutical firm Futura Medical makes the gel.

“FDA set a really high standard in evaluating the effectiveness and safety of De Novo Medical Devices. I’m delighted that we met this standard,” Futura CEO James Barder said in a news release on Monday.

About 30 million American men are affected by erectile dysfunction, where they’re not capable of get or keep an erection for sexual intercourse.

This latest gel will likely be sold in a single-dose tube, CNN reported.

It needs to be applied to the top of the penis before sex. Users may have the option to turn out to be erect inside 10 minutes and maintain that for long enough to have sex in about 65% of those that use it, in response to the corporate.

The product is already sold in Belgium and the UK, where it costs the equivalent of $31.22 in U.S. dollars for a four-pack, CNN reported.

“We don’t have specific pricing details yet, because the pricing will ultimately be determined by the partner who launches Eroxon within the U.S.,” an organization spokesman told CNN.

The timeline for when the product will likely be in the US is unknown nevertheless it could possibly be 2025, CNN reported.

Diseases equivalent to type 2 diabetes can contribute to erectile dysfunction, as can certain medications, anxiety disorders, smoking, drinking excessive alcohol, being chubby or using illegal drugs.

More information

The National Institutes of Health has more on erectile dysfunction.

SOURCE: Future Medical, news release, June 12, 2023; CNN

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