Erectile Dysfunction: First-of-its-kind over-the-counter gel gets FDA approval

Paving the way for the launch of the first over-the-counter erectile dysfunction gel in the United States, Futura Medical’s Eroxon has received marketing authorization from the Food and Drug Administration (FDA), CNN reported. The announcement was made on Monday by the pharmaceutical company. The product has been around for some time in the UK and Belgium and has clearance from the European Union and also parts of the Middle East. Eroxon is a non-medicated hydroalcoholic gel for the treatment of erectile dysfunction in adult males 22 years of age and older. This authorization makes it the first over-the-counter gel intended for the treatment of erectile dysfunction. (Read also: Erectile dysfunction in males: causes, symptoms, prevention tips, effective treatments of this sexual disorder in men)

Erectile dysfunction is a common condition affecting millions of men around the world. According to the WHO, an estimated 150 million men worldwide were affected by erectile dysfunction in 1995 and the number is expected to reach 322 million in 2025. In the United States alone, approximately 30 million people are affected by erectile dysfunction. this condition. Erectile dysfunction is not being able to get and maintain an erection firm enough for sex. It can be either a sign of a physical or psychological condition.

How gel works

CNN reported that the gel comes in a single-dose tube and should be applied to the head of the penis for 15 seconds before intercourse. According to the FDA, after application, the volatile components of the formulation (alcohol and water) evaporate to create a rapid, localized cooling effect on the glans followed by a slower warming effect. This stimulates the nerve endings which lead to tumescence and an erection. The product claims that it can help users get an erection within 10 minutes of applying it. Viagra, on the other hand, is said to take 30-60 minutes to work.

How much does it cost

A four-pack of Eroxon costs about 24.99 at the United Nations, a Futura Medical spokesman said. This would make $31.22 in the US. However, the spokesperson wrote in an email that he did not yet have specific pricing details, CNN reported.

What the doctor says about Eroxon

According to Professor David Ralph, consultant urologist at University College London and former president of the European Society of Sexual Medicine, the product with its topical application will be of particular interest to patients with mild to moderate ED who want a quick onset. of the action.

“Eroxon’s efficacy is remarkable and has been shown to provide clinically meaningful benefits to the majority of ED patients in two Phase 3 studies, but with significantly fewer adverse events than current first-line therapy. With the application topical, will be of particular interest to Patients with mild to moderate ED who desire a rapid onset of action.The lack of drug interactions with prescription products will allow the product to be used with other drugs such as nitrates and other cardiovascular drugs As such, the product will be of great interest to the medical community,” says Professor Ralph on Futura Medical’s corporate website.