Do Over-the-Counter Gels Work for ED?
January 26, 2024

In June of 2023, the Federal Drug Administration approved the first over-the-counter topical gel treatment for erectile dysfunction. Developed by a British pharmaceutical company Futura Medical, who specializes in topical drugs administered through the skin, Eroxon® Stimgel is intended to help men get an erection faster (10 minutes) than currently available oral prescription medications like sildenafil citrate that take up to three times longer.
Based in the Guildford, England, Futura Medical is a research and development pharmaceutical company with a portfolio of innovative products based on the company’s proprietary transdermal technology. While testing a topical medication that contained a form of nitroglycerin, scientists discovered a gel (MED3000) that provided a breakthrough action when topically applied to the head of the penis.
Does it work like the little blue pill?
Yes and no. PDE5 inhibitors like Viagra or Cialis contain nitric oxide and block an enzyme to improve blood flow to the penis creating a harder and fuller erection. Futura’s Eroxon® Stimgel is applied topically to the head of the penis. The gel contains a combination of volatile solvents that promotes vasodilation via a different mechanism. It evaporates in seconds and produces a rapid cooling followed by gradual warming.
Vasodilation happens normally in your body whenever blood vessels widen to allow more blood to flow through them. Chemical messengers are typically triggered by food, beverages, and medications that you consume. As a topical ointment, Eroxon stimulates nerve endings on the glans penis (the head), which is the most sensitive part of the penis. Similar to taking an oral PDE5 inhibitor, ED gel treatments require some form of sexual stimulation to initiate an erection.
Are Topical Gels FDA-Approved ED Medications?
Even though Futura's topical ED gel is a drug-free product that does not require a prescription from a doctor, the FDA still has to approve non-prescription drugs and medical devices before they can be marketed over-the-counter in the U.S. For Eroxon® Stimgel, a De Novo request was issued for the FDA to provide a marketing pathway by providing a reasonable assurance of safety and effectiveness of a novel medical device for which there is no legally-marketed predicate device.
After the Center for Devices and Radiological Health completed its review, the FDA concluded that Futura’s device, and substantially equivalent devices of this generic type, be classified into Class II. Under the generic name non-medicated topical formulation for treatment of erectile dysfunction, the FDA confirmed the safety and effectiveness of the topical formulation when applied to the penis for stimulating nerve endings by inducing temperature changes that leads to an erection.
Eroxon® Stimgel was first approved for use by the European Union as a medical device in 2021 and has also received Great Britian’s UKCA mark. So, the ED treatment gel can be legally purchased over the counter in Europe, Great Britian, and the United States as well as online from major product fulfillment centers. Whilst Eroxon is an effective product proven in clinical studies, ED is still a very complex condition with many causes and not all products are effective in all patients.
What Clinical Studies and Users Have Said...
Although having erectile issues from time to time isn’t a cause for concern, ED can affect your self-confidence and contribute to relationship problems. Common causes are tiredness, stress, too much alcohol, and routine medications. Since ED can also be a sign of clogged arteries, relaxing penile blood vessels can strengthen an erection. So treatments that increase blood flow like PDE5 inhibitors, OTC gels, and low-intensity extracorporeal shockwave therapy are viable treatment options.
Nitric oxide is a natural vasodilator that plays an important role in erectile function as a relaxing agent to smooth penile tissue and widen blood vessels. Although over-the-counter topical ED gels do not contain an active ingredient, they do contain topical glyceryl trinitrate (GTN). When it is absorbed into the blood, the evaporative mode’s cooling action causes it to convert amino acids into nitric oxide that dilates the penile arteries.
Despite the hype around nitric oxide for sexual performance enhancement, the research is not conclusive. Nonetheless, the FDA has approved MED3000 topical gel as a safe and effective medical device for men who choose to try an over-the-counter approach. Clinical trials in the U.K. suggest that Eroxon® Stimgel can be used with condoms, but like most ED treatments, topical ED gels must be combined with some form of sexual stimulation to produce an erection.
Mixed Reviews for Topical ED Gels
Futura Medical announced plans to enter the U.S. market in 2025 but Eroxon® Stimgel is currently available online through Amazon from Advanced Healthcare Products LTD with a suggested delivery date of three to four weeks depending upon your location. The fast-acting topical ED gels cost between $100 to $125 for a 2-pack of 4 single dose tubes. Dosing instructions recommend applying one tube per treatment. Amazon “verified purchase” reviews have been mixed with an overall 1.7 out of 5 stars. Of the 43 global reviews, 77% were 1 star compared to 10% with a 5-star rating.
________________
According to a study by researchers from the John Hopkins Bloomberg School of Public Health, more than 18 million men in the United States over the age of 20 are affected by erectile dysfunction. Nearly 90% of men with ED had at least one risk factor for cardiovascular disease, including diabetes, hypertension, poor cholesterol levels, or being a current smoker and were also less likely to engage in vigorous physical activities. So, consider scheduling a men’s health exam at GAINSWave Buckhead for starters and let our professional staff recommend a treatment protocol personalized for your sexual health care needs.