Over-the-Counter Gel for Treating Erectile Dysfunction Approved by FDA

Over-the-Counter Gel for Treating Erectile Dysfunction Approved by FDA

Erectile dysfunction (ED) is a common sexual dysfunction that affects an estimated 1 in 5 men worldwide, and around 22 million men in the United States. Simply put, ED is the inability to get and maintain an erection firm enough for a satisfying sexual experience. Now, men who have ED may be able to treat it with an over-the-counter topical gel.

In the 1990s, PDE5 inhibitors such as sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra), and avanafil (Stendra) were a significant advancement in the treatment of ED. For the first time, men who were experiencing erectile difficulties could take a pill to help them get an erection.

Despite their effectiveness (particularly in men with ED related to blood flow issues), oral ED medications have a few limitations. First, they cannot be used with certain medications, such as nitroglycerin. Second, oral ED medications can have negative side effects in a small percentage of men. Generally, these side effects are mild and can include facial flushing, temporary blue-green color visual changes, lower back pain, and headaches. Third, these medications are not effective in all men.

Additionally, as pills that are ingested and not a treatment that is directly applied to the penis, oral ED medications can take at least 30-60+ minutes to take effect. Therefore, depending if the medication is taken on-demand, it may not be possible for an individual who is relying on this oral medication to engage in spontaneous sexual activity. 

Recently, strides have been made toward the development and rollout of a new treatment for ED: a topical gel aimed at treating blood flow-related ED. This gel, which is applied externally to the head of the penis before desired sexual activity, is known internally by its developer as MED3000 and externally by the brand name of Eroxon.

Because Eroxon is applied directly to the head of the penis, it is thought to be faster acting than oral ED medications, and it may avoid some of the side effects associated with the pills. However, further testing and external validation will help to determine the role of this new treatment for ED among other therapies.

Though the mechanism of Eroxon is unknown, one theory is that it works by evaporating and stimulating the vascular system and nerve endings in the penis, rapidly warming and cooling the area. This could trigger the release of nitric oxide, relax the blood vessels in the penis, and allow blood to fill the penis for a firm erection.

A 12-week trial of 250 people with ED revealed that 2 out of 3 people reported a clinically meaningful improvement in their erections using Eroxon, and 80% of the individuals with severe ED reported improvements. Although a direct comparison study was not performed, the overall extent of improvement was slightly lower than historical studies of PDE5 inhibitors.  

This gel has been approved by the U.S. Food and Drug Administration (FDA) and can now legally be marketed in the U.S. It is already available in some countries in Europe including Belgium and the UK.

For more information on this topic, please read this publication from The Journal of Sexual Medicine:

Efficacy and Safety of MED2005, a Topical Glyceryl Trinitrate Formulation, in the Treatment of Erectile Dysfunction: A Randomized Crossover Study



Finnis, A. (2023, April 18). What is Eroxon? How the new ‘Viagra gel’ works and where to buy the erectile dysfunction treatment in the UK. https://inews.co.uk/news/health/eroxon-what-viagra-gel-how-work-where-buy-erectile-dysfunction-treatment-uk-2281911

Futura Medical plc. (2023, June 12). Futura’s Fast-Acting Topical Gel for the Treatment of Erectile Dysfunction Granted Marketing Authorisation by the US FDA for Over the Counter Sale. https://www.businesswire.com/news/home/20230612591732/en/US-FDA-Grants-for-Over-the-Counter-Marketing-Authorization-to-Futura-for-Fast-Acting-Topical-Gel-MED3000-to-Treat-Erectile-Dysfunction