An innovative topical gel for the treatment of erectile dysfunction, called Eroxonhas been authorized for over-the-counter marketing in the United States, according to pharmaceutical company Futura Medical, which developed the product.
The company announced on Monday (120) that the US Food and Drug Administration (FDA), an agency similar to Anvisa, has granted marketing authorization for the over-the-counter sale of the gel, which it says is the first topical treatment for erectile dysfunction available. without the need for a medical prescription.
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The FDA confirmed on Monday that Eroxon received a “de novo” classification, a nod to the gel being a new type of product. The decision was taken on Friday (9).
“FDA has set a very high standard in evaluating the efficacy and safety of De Novo Medical Devices. I am delighted that we have achieved this standard,” said James Barder, CEO of Futura Medical, in a press release on Monday.
Eroxon is already available in Belgium and the UK.
In the UK, a four-pack of Eroxon costs around £24.99, a Futura Medical spokesperson said on Monday. This is equivalent to around R$153 in Brazil and US$31.22 in the US.
“We do not yet have specific pricing details as pricing will be determined by the partner launching Eroxon in the US,” the spokesperson wrote in an email. When Eroxon will be available on US store shelves also depends on that partner, but some financial analysts predict that the product could launch as early as 2025.
A product leaflet states that the gel comes in a single-dose tube and must be applied to the head of the penis for 15 seconds before sex. The product’s marketing materials claim that it can help users get an erection within 10 minutes of application.
The erection lasts long enough for successful sex in about 65% of people and should naturally subside, according to the Eroxon website.
In the United States, erectile dysfunction affects approximately 30 million men. The problem happens when someone is unable to get or keep an erection firm enough for satisfactory sexual activity.
Many factors can cause or contribute to erectile dysfunction, including conditions such as type 2 diabetes, medications such as antidepressants, psychological factors such as anxiety, or behaviors such as smoking, drinking too much alcohol, using illegal drugs, or being overweight.
CNN
An innovative topical gel for the treatment of erectile dysfunction, called Eroxonhas been authorized for over-the-counter marketing in the United States, according to pharmaceutical company Futura Medical, which developed the product.
The company announced on Monday (120) that the US Food and Drug Administration (FDA), an agency similar to Anvisa, has granted marketing authorization for the over-the-counter sale of the gel, which it says is the first topical treatment for erectile dysfunction available. without the need for a medical prescription.
read more:
The FDA confirmed on Monday that Eroxon received a “de novo” classification, a nod to the gel being a new type of product. The decision was taken on Friday (9).
“FDA has set a very high standard in evaluating the efficacy and safety of De Novo Medical Devices. I am delighted that we have achieved this standard,” said James Barder, CEO of Futura Medical, in a press release on Monday.
Eroxon is already available in Belgium and the UK.
In the UK, a four-pack of Eroxon costs around £24.99, a Futura Medical spokesperson said on Monday. This is equivalent to around R$153 in Brazil and US$31.22 in the US.
“We do not yet have specific pricing details as pricing will be determined by the partner launching Eroxon in the US,” the spokesperson wrote in an email. When Eroxon will be available on US store shelves also depends on that partner, but some financial analysts predict that the product could launch as early as 2025.
A product leaflet states that the gel comes in a single-dose tube and must be applied to the head of the penis for 15 seconds before sex. The product’s marketing materials claim that it can help users get an erection within 10 minutes of application.
The erection lasts long enough for successful sex in about 65% of people and should naturally subside, according to the Eroxon website.
In the United States, erectile dysfunction affects approximately 30 million men. The problem happens when someone is unable to get or keep an erection firm enough for satisfactory sexual activity.
Many factors can cause or contribute to erectile dysfunction, including conditions such as type 2 diabetes, medications such as antidepressants, psychological factors such as anxiety, or behaviors such as smoking, drinking too much alcohol, using illegal drugs, or being overweight.
CNN
