Research undertaken at Surrey Research Park has stood up to scrutiny as it becomes widely available across the USA
Futura Medical, an innovative pharmaceutical company based at Surrey Research Park in Guildford, is celebrating a huge milestone – its breakthrough erectile dysfunction (ED) treatment MED3000 has been granted US Food and Drug Administration (FDA) Marketing Authorisation for over-the-counter sale.
A well-established UK research and development (R&D) firm, Futura Medical has an impressive portfolio of products based on its proprietary, transdermal DermaSys® technology, designed to offer rapid and targeted local delivery of clinically proven effective treatments via the skin. The company’s two core markets are sexual health and pain.
Futura Medical’s lead product MED3000, which is currently being launched under the brand name Eroxon®, is a fast-acting topical gel clinically proven for the treatment of erectile dysfunction. Eroxon® works by promoting sensory stimulation of the nerves on the head (glans) of the penis by rapid cooling and recovery warming, leading to rapid smooth muscle relaxation, vasodilation and erection.
CEO James Barder explains that it has the potential to be a highly differentiated product by addressing significant unmet needs in the ED market. “MED3000 has two key differentiators,” says James. “The first is its speed of onset. It helps men get an erection within 10 minutes, whilst competitor treatments on the market, such as Viagra, typically take 30 to 60 minutes to have an effect. Removing the need for pre-planning, it offers couples spontaneity and can form part of sexual foreplay.”
The second differentiator is MED3000’s recently-approved over-the-counter status. The treatment is available to purchase without the need for a doctor’s prescription, making it highly accessible. “The UK is an unusual market in that ED treatments can already be purchased over the counter,” continues James. “However, almost everywhere else in the world, these drugs remain prescription only. That’s certainly the case in America, as well as throughout Europe, so point of access is very important. With Eroxon®, you can pick it off the shelf and there are no questions attached. A lot of men with ED are too embarrassed to see a doctor. Therefore, for them – and their sexual partners – to be able to buy a treatment in a credible retail store or through its online website has a significant impact.”
Eroxon®’s efficacy to treat mild, moderate and severe erectile dysfunction has been confirmed by two major clinical studies, conducted in Eastern Europe and the USA. Overall, 63% of consumers achieved MCID (minimal clinically important difference) – the outcome measure that would be noticeable to a patient and be of clinical relevance – at 12 weeks.
Working with its commercial partners, Futura Medical is poised for the long-term distribution of MED3000 across the globe. The rights to the product have been out-licensed in USA, Europe, the Middle East and Latin America to several companies. Whilst initial launches have commenced under the brand name Eroxon®, with the product currently available in the UK and Belgium, further launches are planned for 2023 and beyond.
Futura Medical is celebrating its 20th anniversary this year so MED3000’s FDA approval has come at the perfect time. “It has taken us a number of years to develop MED3000, with our first clinical study starting in 2016,” says James. “It’s a major achievement to get FDA approval, and a great testimony to our small in-house team of 14, who have worked very hard to deliver that. Eroxon® has experienced strong demand since launching and we only expect this to continue.”
Surrey Research Park has played, and continues to play, an important role in Futura Medical’s R&D innovations. James explains that, in the past, the company took advantage of the lab facilities on site and collaborated with fellow tenants. He adds: “One of the things that originally attracted us to the Park was the location as it was close to where our team members lived. Within the Surrey Technology Centre, we’re able to rent fully-serviced offices on a relatively short-term lease. We originally used one unit, but are now using three, and have shrunk it back depending on what’s going on, which has been convenient.”
Now the roll-out of MED3000 is firmly underway, what’s next for Futura Medical? Following the FDA approval, the company will be working to get the drug approved throughout the rest of the world. “We’re working on some other products in the sexual health and pain relief categories, but at the moment, our main focus will be on expanding the innovation pipeline around Eroxon® which, in many markets, we are creating a new over-the-counter category,” explains James. “It’s really a question
of how we can drive that innovation, especially for our commercial partners, who are very interested in having line extensions and other products in the area.”