New treatment for erectile dysfunction approved for over-the-counter sale in the US

This month, the Food and Drug Administration approved the marketing of a new erectile dysfunction treatment called a topical gel Eroxon, meaning it can be sold without a prescription in the United States. It is the first topical treatment for the condition available without a prescription.

Futura Medical, the British pharmaceutical company that produces Eroxon, claims the gel “helps men get an erection from the inside out 10 minutes— faster than current oral options, including Viagra, which can take about 30 minutes to an hour to start. But because full clinical trial data hasn’t been published, it’s unclear how effective Eroxon actually is in helping men in initiating and maintaining an erection, said Dr. Joshua Halpern, a urologist at Northwestern Medicine.

When the gel will become available in the United States “has yet to be determined,” according to a statement from Futura Medical, though it is already available without a prescription in the United Kingdom and in the European Union. The gel has a cooling and warming effect that stimulates the nerves of the penis, causing blood to fill the tissue, said Dr. Arthur Burnett, a professor of urology at Johns Hopkins Medicine who was involved in Futura’s trial of the gel. He called the gel safe and “quite attractive.”

The gel broadens the options for men with erectile dysfunction and adds to the range of prescription drugs, surgical treatments and devices on the market. But the gel is still not a cure, said Kenya Pedrosa Nunes, an associate professor at the Florida Institute of Technology who has studied the condition. “We are still a long way from that,” she said.

And by contrast, there are only two FDA-approved options for treating low libido in women, said Dr. Jagan Kansal, a urologist and co-founder of Down There Urology Clinics in Chicago. “There’s been such a big focus on erections,” he said, “but we as a sexual medicine community haven’t really focused on the women’s part of it.”

What is Erectile Dysfunction?

A person’s nerves, blood, and brain all play a role in erectile function. Developing and maintaining an erection “requires an elaborate balance, a very unique balance, between your nervous system and your vascular system,” said Dr. Nunes.

Erectile dysfunction is the inability to get or maintain an erection, and it affects an estimated 30 million men in the United States, according to the Center for Disease Control and Prevention. Often the condition stems from a lack of adequate blood flow in the penis. It is most common in men above 40 yearsand the older men are, the more likely they are to have it.

The severity of erectile dysfunction may depend on how often a man experiences it, said Dr. Kansas. “I have patients who say, ‘I can get an erection 80 percent of the time, but sometimes I need help’ — that would be considered mild,” he said. “But if they say, ‘I haven’t gotten an erection in 10 years,’ that’s more serious.” And, he added, mild cases can worsen over time: “I call it a progressive chronic condition.”

What Causes Erectile Dysfunction?

Erectile dysfunction is closely linked to several other health problems, especially those that are more common in older men. For example, men with diabetes three times as likely to have erectile dysfunction, according to the CDC The condition can also be the result of hypertension and is considered a predictor of cardiovascular disease; it may be the first indication of cardiovascular disease or diabetes in some men.

Other possible causes of erectile dysfunction include cancer treatment, smoking, alcohol consumption and sleep disturbances, according to the CDC The condition can also be a side effect of certain medications, including antidepressants and allergy medicines, and some research suggests it may linked to cannabis usealthough that connection is still being studied.

There’s also a psychological component — performance anxiety around sex can make it hard to get or keep an erection, said Dr. Halpern. Hormones also play a role, he added, as do low testosterone levels linked with erectile dysfunction.

“All of these things can conspire together,” said Dr. Halpern.

What treatment options are there?

Almost all FDA-approved erectile dysfunction medications are designed to increase blood flow to the penis. Viagra contains sildenafil, which relaxes arteries and smooth muscle and other oral options are in the same class of medications. But if a patient’s erectile dysfunction worsens over time, the oral medications may not be as effective, said Dr. Kansas.

There are injections that can be administered directly into the penis, as well as penile implant surgeries. Vacuum devices and intraurethral suppositories may also be helpful for some patients, said Dr. Halpern.

Since the condition is linked to other health problems, Dr. Kansal recommends that anyone with erectile dysfunction consult a doctor before attempting to tackle it with the over-the-counter gel as soon as it becomes available.

“Even prescription drugs, they don’t fix the underlying blood flow problem, they just cover it up,” he said.