The Food and Drug Administration (FDA) has granted over-the-counter marketing authorization for a gel to treat erectile dysfunction, offering a new, fast-acting option for men who could use a little help in the bedroom. The hydro-alcoholic gel, called Eroxon or MED3000, could be available in the United States in 2025.
An estimated 30 million men in the United States experience erectile dysfunction (ED), or difficulty achieving an erection sufficient for sexual intercourse. ED can have many causes, including cardiovascular disease, diabetes, depression or anxiety, injuries and use of certain medications. Some men who undergo surgery or radiation for prostate cancer can have difficulty getting an erection.
Current treatments for ED include prescription oral medications, such as Viagra (sildenafil) and Cialis (taladafil), medications injected into the penis, such as Trimix and QuadMix (combinations of three or four drugs), vacuum pumps and inflatable implants. The medications work by dilating blood vessels and increasing blood flow, while pumps pull blood into the penis.
Eroxon, from Futura Medical, works differently, alternating cool and warm sensations to stimulate nerve endings in the penis. “Upon application, the volatile components of the formulation (alcohol and water) evaporate to create a rapid, localized cooling effect on the glans penis followed by a recovering slower warming effect. This stimulates the nerve endings leading to tumescence and erection,” according to an FDA announcement.
As described in the Eroxon product leaflet, the gel is applied to the head of the penis 15 seconds prior to sex, which usually triggers an erection within 10 minutes. Viagra and Cialis, in contrast, typically take about 30 minutes to work. The gel was shown to be effective in two Phase III clinical trials. About two thirds of Eroxon users achieved an erection that lasted long enough for intercourse, according to Futura.
The gel is well tolerated with no notable safety concerns. This could offer an advantage over systemic medications, which can cause side effects and drug interactions and are contraindicated for men with certain health conditions. What’s more, the nontoxic gel is safe for oral sex, and it does not damage latex condoms, according to the company.
Eroxon initially launched earlier this year, and it is already available in Belgium and the United Kingdom, where a four-pack costs about $30. Futura, based in England, will work with a U.S. marketing partner, and the gel could hit the shelves here in 2025.
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