MED3000 is a topical gel applied directly to the head (glans) of the penis for the treatment of male erectile dysfunction ("ED").
Results of FM57 enabled Futura to receive approval for MED3000 in the EU as a medical device and with the addition of the FM71 data enabled Futura to submit a regulatory dossier to the US FDA for MED3000 as a medical device for the treatment of ED in October 2022.
MED3000 is authorised as a Class 2B device in the EU/EEA under the European Medical Device Regulation (MDR), allowing MED3000 to be marketed directly to consumers without the need of a doctor’s prescription across the European Union. MED3000 will be the first clinically proven, pan-European topical ED treatment available without a doctor's prescription.
In April 2022, Futura was granted approval for a UKCA certification for MED3000, supplementing the EU MDR approval. The UKCA mark will replace the CE mark in Great Britain from 1 July 2023.
Futura has had a number of productive meetings with the US FDA which has enabled the company to optimise its regulatory submission. In August 2021, Futura agreed with the 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.
The FDA also requested an additional 24-week confirmatory clinical study, known as “FM71” with the protocol agreed with the FDA. In August 2022, Futura announced positive results of FM71, allowing for agreed FDA submission of MED3000 as De Novo Medical Device.
In October 2022, Futura filed a regulatory dossier with the FDA for marketing authorisation for MED3000 as a De Novo Medical Device – with the potential to be the first major ED treatment available OTC in the USA. In March 2023, Futura announced that MED3000 was under active review with the FDA, including a recent meeting, regarding US marketing authorisation. As a regular part of its review process, the FDA asked some additional questions and requested some non-clinical confirmatory data, to which the Company has provided a full response and the requested confirmatory data to enable the FDA to complete their review. Based on the FDA’s published target review period guidelines to include time to review the newly provided information, grant of the De Novo request is now expected to be achieved in Q2 2023.
The EU authorisation 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.
Our commercial partners have filed regulatory submissions in various countries with five regulatory approvals in the Middle East with more to follow.
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. Subjects 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 a rapid speed of onset with an excellent 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 groups, compared to before treatment baseline, along with an excellent safety profile.
Data analysed was positive on measures of clinically meaningful benefit which physicians, ED sufferers and regulators view as increasingly important. MED3000 had a significant clinically meaningful effect in over 60% of patients as calculated using the Rosen1 and Araujo2 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.
FM71 is a multi-centre, randomised, open-label, home use, parallel group, clinical investigation of topically-applied MED3000 gel compared to a well-known US prescription oral medication for the treatment of ED in 96 subjects 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.
FM71 investigated the efficacy and safety of MED3000 gel in male subjects clinically diagnosed with a mix of mild, moderate and severe ED against baseline (pre-treatment). Subjects were recruited from the United States (African Americans), Poland, Georgia and Bulgaria and included men who had organic and psychological ED or a combination of both.
Subjects 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 well-known US prescription oral medication was included in a comparator arm 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 prescription comparator product.
FM71 results were highly positive, meeting all primary and secondary endpoints, were 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 conducted by our commercial partner, enabling FDA submission of MED3000 as De Novo Medical Device in October 2022.
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, and for those ED sufferers seeking fewer systemic side-effects, and a spontaneous intercourse experience. It also provides an important treatment option for those ED sufferers who are currently precluded from using current prescription treatments such as men taking nitrate medication.
David Ralph et al “MED3000, a clinically proven, fast-acting topical product for Erectile Dysfunction with the prospect of being the first globally available OTC treatment for ED” (MED3000 is the codename used when Eroxon® was in the research stage).