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Regulators in Europe are close to approving an unusual over-the-counter treatment for erectile dysfunction (ED): a non-medicated gel that once was used as a placebo, but turned out to work just as well as the agent that was actually being tested. Meanwhile, the FDA just gave the OK for a trial of the treatment to start.

Research has suggested that the gel can spur erections within minutes in some patients after it is applied to the head of the penis. If it actually works, the gel -- technically a medical device, not a drug -- could be the biggest advance in ED since the advent of Viagra-type drugs in the late 1990s and early 2000s.

Investors are impressed: Futura Medical, the British manufacturer of the treatment, saw its stock after the European announcement. But not everyone is ready to jump on the bandwagon.

"It doesn't necessarily sound promising because of the high placebo effect in sexual medicine," said Ryan Terlecki, MD, a urologist at Wake Forest School of Medicine in Winston-Salem, North Carolina, in an interview with MedPage Today. "In some of the early Viagra trials, the placebo effect was extremely high. It also isn't considered ethical to treat people in the U.S. with placebos, even though they are physiologically harmless or should be."

The gel was initially used as a placebo in studies of a nitroglycerin gel called MED2005. Early trial results of MED2005 in 2018 spawned media buzz, with headlines playing on the word "." Nitroglycerin, which dilates blood vessels, is hardly new to medicine. Tablets administered under the tongue have long been used to treat angina.

However, a 2019 of 1,000 men with ED in Europe found that the nitroglycerin gel versus the placebo. In fact, the placebo's effectiveness was roughly equal to that of the active treatment per multiple measurements. Nitroglycerin gel is not approved for ED by the FDA.

"It's clearly not acting as a regular placebo," said Kenneth William James, executive director and head of research and development at Futura Medical, in a of a 2020 call with investors.

At baseline, about 62% of participants said they could insert their penis into their partner's vagina. At a 12-week analysis, that proportion increased to 86% among those who applied the placebo and 83%-86% among those who applied the nitroglycerin gel. Also at baseline, 22% reported having an erection long enough to complete intercourse. At 12 weeks, this increased to 59% among those who applied the placebo and 58%-61% among those who applied the active treatment.

The company said that 60% of participants began to experience erections within 5-10 minutes of applying the placebo. Side effects were rare, with headaches (2.8%) and penile burning (1.2%) reported, they added.

Futura Medical has declined to identify the components of the placebo gel, now called MED3000. The company's states that it is made of a "combination of volatile solvent components" -- a disclosure that's certain to raise questions (and, perhaps, hopes) if mentioned in marketing materials.

In a statement to MedPage Today in response to questions, Futura Medical said the product "gently evaporates to create a unique cooling effect followed by a warming effect. This stimulates nerve sensors in the highly innervated glans penis, leading to smooth muscle relaxation, tumescence and erection."

According to Futura, a European Union agency known as an EU Notified Body has recommended that MED3000 be certified as an approved medical device. The certification is expected to become final by the end of May, the company said, adding that "once received, MED3000 will become the first pan-European topical treatment for erectile dysfunction available without the need of a doctor's prescription."

Meanwhile, the company also reported that it has reached an agreement with the FDA on a small clinical study to be conducted before the treatment is considered as an over-the-counter medical device in the U.S. The phase III, randomized, open-label trial, expected to start in the second half of this year, will include about 100 participants with ED.

The trial will reportedly be by prominent Johns Hopkins University urologist Arthur Burnett, MD, and will compare the gel with tadalafil (Cialis) in terms of safety, speed of onset, and efficacy. "Non-inferiority is not required to be shown," the company told MedPage Today. Participants will include 20 African Americans and 80 patients of Eastern European descent.

Futura Medical declined to speculate on how much the treatment will cost if it is cleared for over-the-counter sale.

The worldwide market for ED products is huge; one recent report estimated of $4.7 billion by 2026. However, many men fail to sustain erections even while they're taking Viagra-type drugs, and other alternatives -- such as penis implants and injections -- are a hard sell.

Hunter Wessells, MD, of the University of Washington in Seattle, said that the new gel product sounds "really exciting."

"I'm always hoping for new drugs in the field since we're just sort of stuck with PDE5 inhibitors," he told MedPage Today in an interview. These drugs include sildenafil (Viagra), tadalafil, vardenafil (Levitra), and avanafil (Stendra).

"But we've had false starts," he noted. "The topical field is tough because if we're just trying to absorb the drug into the penis through the head, it works but not really well. If we're activating different pathways, then that's a game changer. The question is, is it working better than manual stimulation?"

An anonymous blogger known as Neuroskeptic in a March post, noting that the gel "has never been shown to be more effective than any control treatment -- because it was the control treatment ... Overall, I don't think anyone knows how well MED3000 will work if it makes it to market. If it works, I don't think anyone could say how it works -- whether it be the placebo effect, evaporation, or just, well, mechanical stimulation."

Futura declined to comment on the questions raised by Neuroskeptic's blog post. However, in the 2020 call with investors, James said that MED3000 had a "substantially greater effect" than placebo in other studies of ED treatments.

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