New Erectile Dysfunction Treatment Cleared for Over-the-Counter U.S. Sales

Eroxon, a topical gel, “helps men get an erection within 10 minutes,” according to Futura Medical, the manufacturer.

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

Futura Medical, the British pharmaceutical company that produces Eroxon, claims the gel “helps men get an erection within 10 minutes” — faster than current oral options, including Viagra, which can take around 30 minutes to an hour to kick in. But because data from full clinical trials has not been published, it’s unclear how effective Eroxon actually is at helping men initiate and maintain 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, prompting blood to engorge the tissue, said Dr. Arthur Burnett, a professor of urology at Johns Hopkins Medicine who was involved with Futura’s trial of the gel. He called the gel safe and “quite appealing.”

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

And, in contrast, there are only two F.D.A.-approved options for treating low libido in women, said Dr. Jagan Kansal, a urologist and co-founder of the Down There Urology clinics in Chicago. “There’s been such a big focus on erections,” he said, “but we as a sexual medicine society 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 holding an erection “requires an extensive balance, a very unique balance, between your nervous system and your vascular system,” Dr. Nunes said.

Erectile dysfunction is the inability to attain or sustain an erection, and it affects an estimated 30 million men in the United States, according to the Centers for Disease Control and Prevention. Often, the condition stems from a lack of sufficient blood flow inside the penis. It most commonly occurs among men over the age of 40, and the older men are, the more likely they are to have it.

The severity of erectile dysfunction can depend on how often a man experiences it, Dr. Kansal said. “I’ve got 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’re like, ‘I haven’t gotten an erection in 10 years,’ then that’s more severe.” And, he added, mild cases can worsen over time: “I call it a progressive chronic condition.”

What causes erectile dysfunction?

Erectile dysfunction is closely associated with several other health conditions, particularly those that are more prevalent among older men. For example, men with diabetes are three times as likely to have erectile dysfunction, according to the C.D.C. The condition can also result from hypertension and is considered a predictor of cardiovascular disease; it may be the first indication of cardiovascular disease or diabetes in some men.

Other potential causes of erectile dysfunction include cancer treatment, smoking, alcohol consumption and sleep disorders, according to the C.D.C. The condition can also be a side effect of certain medications, including antidepressants and allergy medicine, and some research suggests that it can be linked to cannabis use, though that connection is still being studied.

There is also a psychological component — performance anxiety around sex can make it difficult to achieve or maintain an erection, Dr. Halpern said. Hormones play a role, too, he added, as low testosterone levels are linked with erectile dysfunction.

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

What treatment options are available?

Almost all of the F.D.A.-approved medications for erectile dysfunction are designed to increase blood flow to the penis. Viagra contains sildenafil, which relaxes arteries and smooth muscle, and other oral options belong to the same class of medications. But if a patient’s erectile dysfunction worsens over time, the oral medication may stop being as effective, Dr. Kansal said.

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

Since the condition is linked with other health issues, Dr. Kansal recommends that anyone with erectile dysfunction consult a doctor before trying to address it with the over-the-counter gel once it becomes available.

“Even prescription medication, they’re not fixing the underlying problem of blood flow, they’re kind of just covering it up,” he said.