First FDA Cleared Nonprescription ED Treatment Available for Preorder
Eroxon topical gel addresses a significant unmet need for men experiencing erectile dysfunction.
Customers can now pre-order the Exoron, the first and only FDA cleared, nonprescription treatment for erectile dysfunction (ED), through Amazon. Additional availability is expected at “most major retailers” in October 2024.1
Eroxon is a nonmedicated hydro-alcoholic topical gel indicated for the treatment of ED in adult males aged 22 years and older that works within 10 minutes following application. Compared to existing prescription treatment options—which may take up to an hour to work—this product “addresses a significant unmet need for men experiencing ED.”
Eroxon is the first and only FDA cleared OTC treatment for ED. | Image credit: Vitalii Vodolazskyi - stock.adobe.com
“Introducing to Eroxon to US consumers reflects our belief that sexual health is a critical part of wellness,” said Lisa Paley, president, North America, at Haleon. “We understand how important making meaningful and intimate connections are to one’s wellbeing, and Eroxon helps achieve just that.”
“We are proud to take this bold step to make this first-of-its-kind OTC gel treatment accessible to the millions of men in the US who affected by ED.”
READ MORE: Q&A: Pharmacists Can Play a Key Role in Supporting Men’s Health
Results of clinical studies have demonstrated that Eroxon is safe and effective in men with ED. Although ED can be caused by underlying physical conditions—such as heart disease, high cholesterol, high blood pressure, diabetes, obesity, and smoking—mental health challenges such as stress, anxiety, and depression, among others, can also contribute to ED, particularly among young men.
Two phase 3 clinical trials evaluated the efficacy Eroxon in approximately 300 individuals with mild, moderate, and severe ED.2
The first of these trials was a 12-week, multicenter clinical study of 250 men across 9 European countries (FM57). After 4 weeks of monitoring to determine the extent of their ED using the International Index of Erectile Function – Erectile Function scale and questions 2 and 3 of the Sexual Encounter Profile, participants were monitored for 12 weeks while investigators assessed ED levels to compare to baseline.
During the study, 63% of participants met or exceeded the Minimal Clinically Important Difference (MCID), and 60% of participants saw results within 10 minutes. Speed of onset was “significantly faster” than phosphodiesterase 5 inhibitors, a class of medication that includes sildenafil. In total, 61% 59%, and 80% of men with mild, moderate, or severe ED achieved or exceeded MCID.
The second clinical study (FM71) included 96 participants, half of whom received Eroxon and half of whom received a prescription, oral comparator product. This trial was designed to meet FDA recommendations and took place at sites in 3 European countries and in the US “to confirm efficacy beyond 12 weeks.” Efficacy, safety, and onset of action were assessed multiple times throughout the 24-week clinical study.
This study met its primary endpoint of exceeding MCID of the International Index of Erectile Function – Erectile Function scale at 24 weeks, as well as the secondary endpoint of speed of onset. Results were presented at the 2023 European Society for Sexual Medicine Congress and demonstrated clinical effectiveness of Eroxon in 61%, 55%, and 87% of men with mild, moderate, or severe ED at 24 weeks, with marginal increases in efficacy over the course of the trial.
Adverse events included headache, nausea (in the second clinical study), and a mild localized burning sensation (1% of men and 0.4% of their female partners).
ED affects 30 million men over 22 years of age, and half of all men over the age of 40. As a topical treatment, Eroxon represents a clinical advancement in the treatment of this condition.
READ MORE: OTC Resource Center
