MED3000 is a topical gel applied directly to the head (glans) of the penis for the treatment of male erectile dysfunction ("ED").
MED3000 works through a unique evaporative mode of action. MED3000’s combination of volatile components creates a novel action that stimulates nerve sensors in the highly innervated glans penis by a cooling and recovery warming effect, rapidly leading to smooth muscle relaxation, tumescence and erection as shown on the diagram below.
The glans penis is very highly innervated and there are sensors which are reactive to a range of physical sensations, including touch, pressure and temperature. Futura conducted further research and analysis in 2020 which demonstrated the mode of action for MED3000 as shown in the graph. MED3000 generates a rapid cooling and recovery warming action, promoting a sensory stimulation of the nerves on the glans penis leading to fast smooth muscle relaxation, tumescence and erection.
The 1,000 patient study included approximately 60 centres across nine Central and Eastern European countries. FM57 was a randomised, double-blind, placebo-controlled, home use, parallel group clinical trial. Patients being enrolled into FM57 for the initial four weeks had to attempt intercourse on at least four occasions in order to establish the severity of their ED, known as the pre-treatment ‘baseline’.
FM57, the Phase 3 study was designed to investigate the efficacy and safety of a range of topically applied gels using IIEF-EF and SEP 2 and 3 as co-primary clinical endpoints in mild, moderate and severe ED patients.
In study FM57, MED3000 consistently showed statistical improvement over pre-treatment, baseline and achieved clinically important differences across all ED severities. MED3000 also showed efficacy and rapid speed of onset with a good safety profile.
FM57 demonstrated that MED3000 has the potential to be a highly effective, clinically proven, topical treatment for erectile dysfunction. MED3000 has a unique evaporative mode of action which the Company believes stimulates nerve endings in the glans penis by a cooling and recovery warming effect to cause an erection.
MED3000 results demonstrated a highly statistically significant improvement (p<0.001) in erectile function across ‘pooled’ patient severities (mild, moderate, and severe) as well as being statistically significantly superior within the separate mild, moderate and severe patient groups, compared to before treatment baseline, along with an excellent safety profile.
Data analysed was positive on measures of clinically meaningful benefit which physicians, patients and regulators view as increasingly important. MED3000 had a significant clinically meaningful effect in 60% of patients as calculated using the Rosen and Araujo statistical methods, standard assessment techniques for measuring Patient Reported Outcomes recognised and accepted by leading ED experts.
MED3000 begins to work immediately in some patients, with over 60% of patients seeing onset of their erection within 10 minutes of application, substantially faster than reported for PDE5i's (oral tablets) with significant benefits for spontaneous rather than pre-planned sexual intercourse.
Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patient, or their female partners.
Futura's breakthrough, fast-acting topical gel formulation MED3000, will be the first clinically proven, pan-European topical treatment for adult men with ED available without a doctor's prescription.
In April 2021, Futura announced that it had received its MDR EU Quality Management Certificate for the placing on the market of MED3000 as a Class 2B medical device known as MED3000 ("CE mark approval"). A Class 2B approval is by definition an approval allowing marketing of MED3000 as a treatment without the need of a doctor’s prescription across the European Union.
With the CE mark approval, this also paves the way for faster approval in many countries around the world including the Middle East, Africa, certain Far East countries and Latin America who allow “fast-track” review based on their recognition of the EU CE mark. The CE marking is also recognised in Great Britain until 30 June 2023 and Futura has now received the new post-Brexit UKCA mark which will extend approval in Great Britain beyond this date.
FDA’s guidance documents indicate that their preference is to adopt an interactive and iterative approach to data requirements through pre-submission meetings with sponsors. According to FDA, careful considerations of their feedback may improve the quality of subsequent submissions, shorten total review times and facilitate the development process for new devices.
In 2020, the FDA agreed that an application may be made for MED3000 as a medical device for ED treatment, via the De Novo reclassification regulatory pathway.
Following a number of productive meetings in August 2021 Futura agreed with FDA the design of a “Human Factors” study to achieve OTC classification. Successful completion of the Human Factors study was announced in December 2021, with 32 subjects recruited. It was demonstrated that individuals are able to correctly self-diagnose ED and to make correct self-selection decisions by considering their own health history and the instructions for use and warnings on the label. Overall, there was a very high degree of comprehension of the label and leaflet to increase confidence that the product will be used appropriately in an OTC setting.
These results therefore support the regulatory submission for OTC designation and will enable Futura to finalise the OTC product label for a US filing.
FDA has also requested an additional six-month small confirmatory clinical study, known as “FM71” And the protocol was agreed with FDA.
FM71 is a Phase 3, 24-week multicentre, comparative, randomised, open-label, home use, parallel group study in 100 subjects with mild, moderate or severe ED. FM71 was fully recruited by the end of December 2021 using subjects from Eastern Europe and the US. Co-primary endpoints were agreed with FDA as significant improvement with MED3000 from baseline (pre-treatment) ED, and ensuring that the change from baseline is clinically important defined as at least a 4-unit change on the internationally recognised IIEF-EF scale, a standard assessment technique for measuring Patient Reported Outcomes. Secondary endpoints include FDA agreed criteria to support fast-acting claims, a key product differentiator.
A Tadalafil 5mg (the active in Cialis®) comparator arm is included for informational purposes only to assess relative safety, speed of onset and overall efficacy. This will more accurately enable FDA to determine the relative benefit/risk ratio of MED3000 versus a commercially available comparator; albeit only available on prescription.
Timelines remain on track to enable planned US regulatory submission by the end of Q3 2022, targeting US FDA grant of the De Novo request and OTC designation in Q1 2023.
Run-in period to establish degree of patient's erectile dysfunction ("Baseline")
N = 50
Tadalafil 5 mg
N = 50