FDA Approves First-Ever OTC Erectile Dysfunction Gel

14 Jun 2023 • The FDA approved the drug, called Eroxon, on Friday, noting that it is a first-of-its-kind topical treatment for ED. Eroxon is clinically proven as an effective treatment for ED, after going through two clinical trials in Europe and the US. In both clinical trials, it was found that Eroxon was effective in treating ED and found to help men get an erection within 10 minutes. The FDA confirmed Monday that Eroxon has been granted a “de novo” classification, a nod to the gel being a new type of product.

“FDA set a very high standard in evaluating the effectiveness and safety of De Novo Medical Devices. We are delighted that we met this standard,” the drugmakers said in a news release Monday. 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.

According to the product's leaflet, Eroxon "the gel comes in a single-dose tube, & stimulates blood flow in the area through a unique physical cooling then warming e­ffect." The company said on the product's website that 65% of people who used the drug have successfully obtained the desired results.

Source: CNN Health | Read full story

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