A new type of topical gel for erectile dysfunction has been approved by the U.S. Food and Drug Administration (FDA) that may offer some men a way to manage the condition without taking prescription pills like Viagra...CONTINUE READING
or Cialis
.
The gel, called Eroxon, is the first over-the-counter topical erectile dysfunction (ED)
treatment approved by the FDA, said the company that developed it, Futura Medical, in a statement
.
“Eroxon, which is fast-acting with minimal side effects, has the opportunity to provide an alternative option and significant benefits compared with existing ED treatments, especially for those patients seeking a spontaneous intercourse experience, as Eroxon helps users get an erection within 10 minutes,” says James Barder, the chief executive officer of Futura Medical.
Because of how quickly and easily it can be used during foreplay, Eroxon can help “restore spontaneity and intimacy in the relationship whilst offering an excellent safety profile,” Barder adds.
Eroxon was approved as a medical device because it’s a drug-free gel that doesn’t have any active pharmaceutical ingredients, the company said. The FDA approved Eroxon as a “de novo,” or new, medical device on June 9, according to a regulatory update on the FDA’s website
.
It works by rapidly cooling and then warming the tissue when applied to the ***, a process that stimulates nerve endings and increases blood flow to produce stronger erections, according to the company’s website
.
Eroxon is sold in single-dose tubes and should be applied to the head of the *** for 15 seconds, according to user instructions
provided with the product. It can cause erections within 10 minutes of application, and erections last long enough for what the company called “successful sex” for about 65 percent of people, according to the company’s website
.
In late-stage clinical trials
, the company didn’t identify any serious side effects for men or for their female partners. In some instances, men experienced a burning sensation on the *** in these trials, and one of their female partners noted vaginal irritation, Barder says, but it’s not clear whether these side effects were caused by Eroxon. Some people also reported headaches.
Futura Medical is still in discussions with potential retailers and has not yet determined how much Eroxon will cost in the United States, Barder says.
Erectile dysfunction is common, affecting about 30 million U.S. men, according to the National Institutes of Health
. People are more likely to develop the condition when they’re older, have overweight or obesity, or smoke.
The most widespread medical treatments for erectile dysfunction
are prescription drugs such as Viagra, which can’t always be used by men with cardiovascular disease
because of the risk of dangerously low blood pressure.
