Approved in the US and Europe as an over-the-counter erectile dysfunction treatment, Eroxon works by an evaporative mode of action, leading to smooth muscle relaxation. Image credit: Shutterstock/Drazen Zigic.

M8 Pharmaceuticals will supply Futura Medical’s erectile dysfunction (ED) gel to more countries in Central and South America after the two companies expanded their partnership. 

UK-based Futura entered a licensing agreement with US-headquartered M8 Pharmaceuticals in August 2021. The deal was for the rights to exclusively develop and commercialise Futura’s topical erectile dysfunction gel, sold under the brand name Eroxon, in Brazil and Mexico.

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M8 has taken up its right to extend the licensing agreement to a further 14 countries in the Central and South American region.

M8 is headquartered in the US but focuses on therapeutic distribution in Central and South America.  

Futura stated the extension does not affect the commercial terms or duration of the agreement. As per the original deal, Futura receives payments on all sales of Eroxon, also known as MED3000, by M8, including up to $8.5m in milestone payments.

Eroxon was approved by the US Food and Drug Administration (FDA) in June 2023. The product became the first over-the-counter (OTC) topical gel available in the US for erectile dysfunction treatment. The gel has been available in Europe since 2021 and in the UK since last year.

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In July 2023, Futura and GSK spin-out Haleon partnered to commercialise the OTC gel in the US in a deal with potential milestone payments of up to $45m, including an upfront payment of $4m.

The gel was approved for marketing in Mexico in October 2023.

In interim results for H1 2023, Futura stated that the gel generated sales of £1.7m ($2.08m) in Europe, where it is sold under the name Eroxon.

The gel is topical glyceryl trinitrate (GTN) delivered using the Futura’s DeraSys platform, which includes chemicals that help permeation through the skin. However, as the treatment itself works without a chemical reaction, it is classed as a medical device. The cooling creates a natural release of nitric oxide from the absorbed GTN, which leads to vasodilation in the penile arteries. The company says an erection with Eroxon is possible within 10 minutes

The mechanism is notably faster than popular oral medications such as sildenafil, known by the brand name Viagra and marketed by Pfizer; and tadalafil, which is marketed by Eli Lilly as Cialis. Both drugs have generic equivalents available and are PDE5 inhibitors that can take 30 to 60 minutes to kick in.

Futura CEO James Barder said: “We look forward to a significant number of new country launches in 2024 across the world.”