Futura Gains EU CE Mark For Drug-Free OTC Erectile Dysfunction Treatment
Executive Summary
Futura Medical has received a CE Mark for its MED3000 erectile dysfunction treatment, which combines in gel form a mixture of volatile and non-volatile ingredients.
Erectile dysfunction (ED) sufferers in Europe will soon be able to buy without a prescription a drug-free new treatment thanks to the recent European Union approval of Futura Medical’s MED3000 medical device.
Combining in gel form a mixture of volatile and non-volatile ingredients applied directly to the tip of the penis, MED3000 has received approval from a notified body a CE Mark under the EU Medical Devices Regulation (2017/745) as a Class II(b) medical device.
This means that the device can be sold OTC in all EU member states, as well as the UK until 30 June 2023, by which time a specific UKCA mark has to be obtained.
“We are excited to be able to offer MED3000 to millions of patients in Europe as the first, clinically proven OTC treatment for ED.” – Futura CEO James BarderEuropean approval also paves the way for approval in many countries around the world, including in the Middle East, Africa, the Far East and Latin American – regions which allow fast-track review based on recognition of an EU CE mark, the firm pointed out.
"Today marks a transformational milestone for the company,” commented Futura CEO James Barder, as the approval was announced on 30 April. “We are excited to be able to offer MED3000 to millions of patients in Europe as the first, clinically proven OTC treatment for ED.”
“MED3000 is a highly differentiated product, with a rapid speed of onset addressing significant unmet needs, across all patient severities in the $5.6bn global ED market,” he added. “We look forward to further MED3000 marketing approvals in the coming years in multiple regions across the world, including the USA and Asia.”
MDR Bottleneck
Speaking just before the CE mark announcement, Futura executive director and head of R&D, Ken James told HBW Insight that approval was taking a “frustratingly long time” following the successful completion of a comprehensive technical review by the EU notified body dealing with MED3000.
“There were 26 questions, which we answered just before Christmas,” James explained. “We had a couple of additional questions come back from the notified body early in the new year, which we answered immediately, and then we learnt that we had moved forward to the next stage which was a final clinical panel review.”
“So, we held our breath for a couple of weeks in case any zingers came our way, but none did,” he continued. “We got signed off, there were no additional questions.”
The reason final approval was taking so long, James said, was because of bottlenecks that had formed as a result of many companies trying to get approvals under the new MDR, a process which has been further delayed due to COVID-19.
Next Steps
Now that the firm has the CE mark for MED3000, Futura CEO Barder said the next step is to secure partnerships for commercialisation and to scale up manufacturing ready for launch.
“We are very much now working on scaling up manufacturing to cope with expected volume demand and we’re making good progress on that,” Barder revealed. “That is being developed in parallel with commercial discussions.”
“We have retained specialist advisors in the sector, and we are going through a process of reviewing commercial opportunities,” he continued. “We’ve had a number of non-binding offers which may be translated into binding offers.”
“We are making good progress on that,” Barder added. “We expect to announce deals during the year.”
Competitive Advantage
In terms of the commercial opportunity, James told HBW Insight in a previous interview that MED3000’s unique drug-free mode of action, which utilises Futura Medical’s proprietary DermaSys delivery technology, set it apart from other ED treatments. (Also see "Watch Out Viagra! UK’s Futura Set To Shake Up Global ED Market With MED3000" - HBW Insight, 7 Jul, 2020.)
While ED drugs are available OTC in some countries – notably, Pfizer’s Viagra Connect (50mg sildenafil), which was switched in the UK in 2017 – the side-effects related to their potent pharmaceutical ingredients and having to wait for the drug to kick in before having sex are significant barriers to use, James argued.
As a topical gel, MED3000 can be applied directly to the penis, James explained, leading to an erection (clinical studies so far have shown) within ten minutes.
“With a product that is topically applied, it can be applied by the male or the male’s partner as part of foreplay and has a very fast on-set of action, allowing spontaneity,” he continued. “This is a key advantage.”
MED3000 has a unique physical action, James pointed out, containing five or six ingredients; a mix of volatile and non-volatile ingredients.
“The way we believe it acts is that the volatile components in the gel evaporate off very quickly and in evaporating off, produce a significant drop in temperature followed by a gradual warming effect,” he said.
“This combination of cooling and warming creates a sensory sensation which stimulates the nerve endings in the highly innervated glans penis, ultimately causing an increase in blood flow that in turn produces an erection.”
“It’s a very unique mode of action and very safe, as you might imagine, compared to a drug-based mode of action that has all the attendant side effects, due to their interrupting a number of other body processes as they go through the systemic circulation.”