Topical Gel for Erectile Dysfunction Gets FDA Approval for OTC Sale

TUESDAY, June 13, 2023 (HealthDay News) -- 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.

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 percent 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.

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