UK-based Futura Medical has signed a deal with healthcare company Haleon to commercialise its over-the-counter (OTC) erectile dysfunction gel, Eroxon, in the US.

Eroxon, also known as MED3000, became the first erectile dysfunction gel available to patients in the US without the need for a doctor’s prescription following approval from the US Food and Drug Administration (FDA) last month.

Haleon, which spun out from GlaxoSmithKline (GSK) last year, will now be responsible for the rollout of Eroxon in the US – overseeing regulatory, development, marketing, and commercialisation progress for the treatment.

In exchange, Futura will retain royalty payments on sales of the gel and receive an upfront payment of $4m. The sexual health pharmaceutical company is also in line to receive commercial and sales milestone payments up to a potential $45m.

Shares in Futura rose 12% at market open on Monday 17 July compared to the pre-announcement market close (14 July).

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Futura’s gel, which is already available in the UK and Belgium, is directly applied to the glans of the penis and stimulates nerve sensors by a cooling and recovery warming effect. The gel is topical glyceryl trinitrate (GTN) delivered using the company’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.  

PDE5 inhibitors such as sildenafil, known by the brand name Viagra and marketed by Pfizer, and tadalafil, which is marketed by Eli Lilly as Cialis – both of which have generic equivalents available – dominate the market share for erectile dysfunction treatment, although they can take 30 to 60 minutes to kick in and require a prescription.

Eroxon’s evaporative mode of action, which leads to smooth muscle relaxation, means an erection is possible within ten minutes, according to Futura.

Futura’s CEO, James Barder told Medical Device Network: “Demand for clinically proven ED treatments has increased over the last three years but the unmet need remains substantial with around 22 million men suffering ED in the US, the majority of which do not currently treat their condition. This will be the first major clinically proven treatment in the US available without the need of a doctor’s prescription thereby giving significantly greater ease of access.

“Futura is committed to building a long term profitable global distribution network for MED3000, this is progressing well with agreements in place for USA, Mexico, Brazil, EU, UK, Switzerland, Middle East and Korea.”