Erectile Dysfunction Gel Gets U.S. FDA For OTC Sale

A first-of-its-kind topical gel for the treatment of erectile dysfunction (ED), called Eroxon, has been authorized for over-the-counter (OTC) marketing in the US, Jacqueline Howard reported for CNN.

Photo Insert: Eroxon is already available in Belgium and the United Kingdom.

Futura Medical, which developed the gel, announced on Monday that the US Food and Drug Administration (FDA) granted marketing authorization for the OTC sale of the gel, which it says is the first topical ED treatment available without the need for a prescription.

The gel comes in a single-dose tube and should be applied to the head of the penis for 15 seconds before sex. The company says the product can help users get an erection within 10 minutes of application. More than 30 million Americans are afflicted with ED.

The FDA confirmed Monday that Eroxon has been granted a “de novo” classification, a nod to the gel being a new type of product. The de novo decision was made Friday.

“FDA set a very high standard in evaluating the effectiveness and safety of De Novo Medical Devices. I am delighted that we met this standard,” James Barder, chief executive officer of Futura Medical, said.

Eroxon is already available in Belgium and the United Kingdom. In the UK, a four-pack of Eroxon costs about £24.99, a Futura Medical spokesperson said Monday. That’s equivalent to about $31.22 in the US.

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