Over-the-counter gel for erectile dysfunction gets FDA approval | Health
Paving the way for launch of first-ever over-the-counter gel for erectile dysfunction in the US, Futura Medical’s Eroxon has received marketing authorisation from Food and Drug Administration (FDA), reported CNN. The announcement was made on Monday by the pharmaceutical company. The product has been around in the UK and Belgium for some time now and has authorisation from the European Union, and parts of the Middle East also. Eroxon is a non-medicated hydro-alcoholic gel for treatment of erectile dysfunction in adult males of 22 years and above. This authorization makes it the first over-the-counter gel intended to treat erectile dysfunction. (Also read: Erectile dysfunction in males: Causes, symptoms, prevention tips, effective treatments of this sexual disorder in men)
According to Professor David Ralph, Consultant Urologist at University College London and past president of the European Society of Sexual Medicine, the product with its topical application, will be of particular appeal to mild to moderate ED patients who want a fast onset of action.(Futura Medical)
Erectile dysfunction is a common condition affecting millions of men all over the world. According to WHO, 150 million men worldwide were estimated to have been affected by erectile dysfunction in 1995, and the figure is expected to touch 322 million in 2025. In US alone, around 30 million people are affected by the condition. Erectile dysfunction is not being able to get and keep an erection firm enough for sex. It can both be a sign of a physical or psychological condition.
How to gel works
CNN reported that the gel comes in a single-dose tube and must be applied to the head of the penis for 15 seconds prior to sex. According to FDA, upon application, the volatile components of the formulation (alcohol and water) evaporate to create a rapid, localized cooling effect on the glans penis followed by a recovering slower warming effect. This stimulates the nerve endings leading to tumescence and erection. The product claims that it can help users get an erection within 10 minutes of application. Viagra on the other hand is said to takes 30 -60 minutes to work.
How much it costs
A four-pack Eroxon costs about £24.99 in the UN, a Futura Medical spokesperson said. This would make it $31.22 in the US. However, the spokesperson wrote in an email that they don’t have specific pricing details as yet, reported CNN.
What doctor says about Eroxon
According to Professor David Ralph, Consultant Urologist at University College London and past president of the European Society of Sexual Medicine, the product with its topical application, will be of particular appeal to mild to moderate ED patients who want a fast onset of action.
“The efficacy of Eroxon is remarkable and has been shown to deliver clinically meaningful benefits to most sufferers with erectile dysfunction in two Phase 3 studies but with significantly lower adverse events than current first line therapy. With topical application, it will be of particular appeal to mild to moderate ED patients who want a fast onset of action. Lack of drug interactions with prescription products will enable the product to be used with other medications such as nitrates and other cardiovascular drugs. As such the product will be of great interest to the medical community,” states Professor Ralph on company website of Futura Medical.
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