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

2023-06-12

上市批准

TUESDAY, June 13, 2023 -- Men with erectile dysfunction will now have the option 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 very high standard in evaluating the effectiveness and safety of De Novo Medical Devices. I am 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 able to get or keep an erection for sexual activity.

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

It should be applied to the head of the penis before sex. Users may be able to become erect within 10 minutes and maintain that for long enough to have sex in about 65% of those who use it, according to the company.

The product is already sold in Belgium and the United Kingdom, 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, as the pricing will ultimately be determined by the partner who launches Eroxon in the U.S.,” a company spokesman told CNN.

The timeline for when the product will be in the United States is unknown but it could be 2025, CNN reported.

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

Sources

Future Medical, news release, June 12, 2023

CNN

Posted June 2023

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