FDA Approves a Topical Erectile Dysfunction Treatment, And It’s Over the Counter

Shelves in a pharmacy

The FDA just approved a new erectile dysfunction treatment that can be sold over the counter. This gel goes directly on the penis, works in just 10 minutes, and has few side effects. Some experts, however, aren’t convinced it works all that well.

Many men experience erectile dysfunction (ED) at some point in their lives. Studies have suggested that anywhere from one third to one half of all men have had trouble getting or keeping an erection. We also know that the likelihood of this condition increases with age.

Since Viagra burst on the scene in 1998, the main treatment for ED has been oral medications known as PDE5 inhibitors. PDE5 is an enzyme that can prevent a sufficient amount of blood from getting to the tissues in the penis. Blocking this enzyme makes it easier for blood to flow to the penis and harder for it to flow back out, which is why the medication can help people with penises get and keep erections.

These medications have side effects, however, including headaches, flushing, upset stomach, nasal congestion, diarrhea, dizziness, and a rash. They have also been known to cause vision issues, including blurry vision, a blue tinge to everything in the field of vision, and increased brightness of lights. As the commercials famously say, these medications can also cause erections that last too long (more than 4 hours) and require medical help.

Moreover, these drugs are expensive—without insurance they can be as much as $90 per pill.

The hope is that this new topical treatment can help people with ED without the side effects and for far less money. The gel, called MED3000, will be sold under the brand name Erexon. Directions say to rub a pea-size amount onto the head of the penis for 15 second before sex and suggest it should work within 10 minutes.

The gel does not contain any drugs, instead it has ingredients like alcohol, glycerin, and carbomer and works locally by offering a rapid cooling sensation. Even the principal investigator on MED3000’s clinical trials is not quite sure why this works but he told the Washington Post that “it seems to generate enough sensitivity to cause an erection.” Futura, the gel’s manufacturer, has said that by the end of one clinical trial (which only included 96 men), 85 percent of participants who used MED3000 said they felt sex could be spontaneous at least some of the time. The product also worked faster than PDE5 drug. Futura admitted, however, that the oral medications worked better. The company has not released the full clinical trial data citing concerns about competition.

It’s not known when the product will hit shelves in the U.S. though some industry analysts say it could be as late as 2025. We also don’t know what the price will be here, but the gel is already available in the UK where a four pack costs £24.99 (or about $31.00).

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