First over-the-counter erectile dysfunction gel gets FDA nod, will hit shelves in 2025
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The US Food and Drug Administration(FDA) on Friday authorized pharmaceutical company Futura Medical Developments Limited to market its gel that claims to treat erectile dysfunction (ED). The authorization marks the availability of the first ever over-the-counter (OTC) gel in the U.S. for ED.
Erectile dysfunction is defined as the persistent inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
The gel Eroxon(MED3000) is a non-medicated hydro-alcoholic gel, which can be used by males aged 22 years and over. It is applied directly to the head(glans) of the penis. “Helps you get an erection within 10 minutes,” says the packaging of the product which comes in four single-dose tubes.
Meanwhile, Twitter is up in arms over the marketing approval of the product. Many have taken to the microblogging website to comment on the 'hypocrisy' that the ED gel will soon be easily available in the market for men, but what about over-the-counter birth control for women? One currently needs a prescription for birth control pills in the U.S.
How does the gel work?
The key components of Eroxon’s formulation — water and alcohol — evaporate to create a rapid cooling effect on the glans of the penis followed by a slower warming effect. This stimulates the nerve endings of the penis glans and eventually leads to an erection, the company claims.
Futura advises Eroxon’s user to massage the gel for 15 seconds. “Patients or their partners can apply the gel directly to the man’s penis as part of foreplay,” said the company.
Better than oral tablets?
Eroxon is supported by the completed Phase 3 studies FM57 and a US confirmatory Phase 3 study FM71.
The Phase 3 FM57 study was conducted across nine Eastern and Central European countries and had a sample size of 1,000 patients. The study was a randomized, home-use, placebo-controlled clinical trial. Known as the pre-treatment baseline, patients had to attempt intercourse on at least four occasions over four weeks to establish the severity of their ED.
The study was designed to investigate the efficacy and safety of Eroxon and also using the IIEF-EF score(which differentiates ED based on its severity), and Sexual Encounter Profile (which is a log diary completed after every sexual encounter) as co-primary clinical endpoints.
The findings of the study said that Eroxon began to work immediately in over 60 percent of the patients, who witnessed an onset of an erection within 10 minutes of application. The company says this is substantially faster than oral tablets.
Eroxon likely to hit US shelves in 2025
Eroxon in the UK costs about £24.99 ($31.22 in the U.S.), a Futura Medical spokesperson told CNN.
“We don’t have specific pricing details yet as the pricing will ultimately be determined by the partner who launches Eroxon in the U.S.,” said the spokesperson.
The Massachusetts Male Aging study of 1994 surveyed 1,709 non-institutionalized men aged between 40 and 70 years. The study found that the combined prevalence of minimal, moderate, and complete ED was 52%.
The prevalence of ED disrupts the lives of at least one in five men globally. About 22 million men suffer from ED in the U.S. alone. Many patients continue to suffer dissatisfaction with the current available therapies.
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