MED3000 is a topical gel applied directly to the head (glans) of the penis for the treatment of male erectile dysfunction ("ED").
MED3000 is a topical gel applied directly to the head (glans) of the penis for the treatment of male erectile dysfunction ("ED").
MED3000 is a unique formulation of DermaSys® using volatile solvent components specifically tailored for the treatment of ED.
MED3000 is a treatment applied directly to the head (glans) of the penis and massaged for 15 seconds. Patients or their partners can apply the gel directly to the man’s penis as part of foreplay. It is fast-acting helping men get an erection within 10 minutes, and easy to use helping to restore spontaneity and intimacy in the relationship whilst offering an excellent safety profile.
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.
Natural NO production
NANC
neurons
Endothelial cells
MED3000
Novel evaporative
action stimulates
nerve sensors in the
highly innervated
glans penis through
temperature, touch
and pressure
NO
GMP
GTP
PDE5i: PDE5 inhibition
Oral treatment with systemic absorption. Primarily selective for PDE5
cGMP-specific phos-phodiesterase type 5
Soluble guanylyl cyclase
cGMP
Smooth muscle relaxation
Tumescence and penile erection
MED3000 is supported by efficacy and safety data from a range of studies including the completed Phase 3 studies FM57 and a US confirmatory Phase 3 study, FM71.
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 over 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 also requested an additional 24 week confirmatory clinical study, known as “FM71” and the protocol was agreed with FDA.
In August 2022, Futura announced positive results of FM71, and is on track to file the dossier with the US FDA by the end of September, targeting marketing authorisation by the FDA of MED3000 in Q1 2023 as the first major ED treatment available OTC throughout the USA.
FM71 is a multi-centre, randomised, open-label, home use, parallel group, clinical investigation of topically-applied MED3000 gel compared to oral tadalafil (5mg) tablets for the treatment of ED over a 24-week period. The trial design and clinical endpoints were agreed with the FDA as a confirmatory clinical trial for the US regulatory dossier for MED3000 which we continue to target filing by the end of September 2022.
FM71 investigated the efficacy and safety of MED3000 gel in 96 male patients clinically diagnosed with a mix of mild, moderate and severe ED against baseline (pre-treatment). Subjects were recruited from United States (African Americans), Poland, Georgia and Bulgaria and included men who had organic and psychological ED or a combination of both.
Patients enrolled into the FM71 study 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 ‘baseline’, after which MED3000 was used as per trial protocol for 24 weeks.
A tadalafil 5mg (the active in Cialis®) comparator arm was included for informational purposes only to assess relative safety, speed of onset and overall efficacy. This enabled the FDA to determine the relative benefit/risk ratio of MED3000 versus a commercially available comparator accurately; albeit only available on prescription.
Co-ordinating investigator:
Professor Arthur Burnett
MD, MDA, FACS, Patrick C Walsh Distinguished Professor of Urology
Johns Hopkins University School of Medicine, Baltimore, US
Past President of the Sexual Medicine Society of North America
FM71 results are highly positive, meeting all primary and secondary endpoints; are in line with data generated in the previous Phase 3 clinical study (“FM57”) and are broadly comparable with results from a recent “real world”, home user study.
Data demonstrates that MED3000 presents an effective clinically proven treatment for erectile dysfunction with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for Over the Counter classification.
It is expected to provide an alternative to existing ED treatments, that require a doctor’s prescription, for those patients seeking fewer systemic side-effects, and a spontaneous intercourse experience. It also provides an important treatment option for those patients who are currently precluded from using current prescription treatments such as those men taking nitrate medication.
Futura is on track to file the dossier with the US FDA by the end of September, targeting marketing authorisation by the FDA of MED3000 in Q1 2023 as the first major ED treatment available OTC throughout the USA.