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 an evaporative and unique mode of action. MED3000’s combination of volatile solvent components creates an evaporative and novel action that stimulates nerve sensors in the highly innervated glans penis 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. Further company analysis and research has indicated that the cooling from the evaporation of these specific combinations of solvents, with subsequent warming, following topical application of the MED3000 gel, stimulates the required physical response in order to achieve an erection.
The 1,000 patient study included approximately 60 centres across nine Central and Eastern European countries. FM57 was a dose ranging, 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 topically applied Glyceryl Trinitrate (GTN) (MED2005 0.2%, 0.4%, 0.6% GTN) against that of the placebo using IIEF-EF and SEP 2 and 3 as co-primary clinical endpoints in mild, moderate and severe ED patients. An ED-specific DermaSys® formulation (now known as MED3000) was used as a control arm (placebo) following regulatory requirements to have a placebo as near as possible to the active product.
4 week run-in-period to establish degree of patient's erectile dysfunction ("Baseline")
N = 300 patients
6 months use*
N = 100 patients
12 months use*
* Following the FM57 results the open label phase was discontinued prematurely and is no longer active
The results from the Phase 3 clinical study were unexpected. MED3000 achieved positive results, with a striking consistency in being significantly statistically superior to baseline for all three co-primary endpoints (using validated and globally accepted measurement tools), as well as being statistically significant in each separate cohort of severity (mild, moderate and severe). At one, two and three months treatment time points, highly statistically superior improvement over baseline was achieved.
Key secondary endpoints were also all statistically met compared to the pre-treatment baseline. Data analysed was positive on measures of clinically meaningful benefit which physicians, patients and regulators view as increasingly important. All formulations 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 60% of patients seeing onset of their erection within 5-10 minutes of application, substantially faster than on demand oral tablets with significant benefits for spontaneous rather than pre-planned sexual intercourse.
FM57 demonstrated that MED3000 is 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 to cause an erection.
All formulations tested in FM57, including MED3000, have demonstrated positive and statistically significant efficacy results against baseline data together with excellent safety profile. MED3000 will be of high interest to the Medical Community for those patients who are seeking a very rapid onset of action and a very low side-effect profile. It will likely find use in the substantial number of patients, especially those with ED of a mild to moderate nature and those patients who are contraindicated for use with existing products.
Consultant Urologist and Past President of the European Society of Sexual Medicine
In February 2020 Futura commenced formal proceedings for the approval of MED3000 as a Class IIB medical device in Europe. In early July the Company submitted the Technical Dossier on MED3000 for review to the designated European Notified Body3. In parallel since February 2020, the Company had been progressing the development of its Quality Management System (QMS) and in early August received a positive audit opinion from the Company’s designated Notified Body. These milestones pave the way for the Notified Body to complete its review of MED3000 under the new European Medical Device Regulations (MDR). Futura continues to target a 2021 European approval date.
Initial presentation of existing clinical evidence from the MED3000 FM57 phase 3 study was made at a US Food and Drug Administration (“FDA”) pre-submission meeting in late February 2020.
Following receipt of the formal meeting minutes from the first pre-submission meeting in early April, the FDA agreed to a De Novo medical device application for MED3000 and invited Futura to pursue another pre-submission meeting once the company was in receipt of the final clinical study report for FM57.
In mid-July the company announced that a second pre-submission meeting with the FDA had taken place. As a result of this meeting the Board believes a pathway to a marketing approval for MED3000 in the USA has been established, and importantly, without the need for a doctor's prescription.
During the meeting the FDA indicated a requirement for certain supplementary clinical efficacy data beyond the FM57 phase 3 study completed in 2019. This additional data will likely require a further small clinical study where patients with ED may receive MED3000 for a six-month treatment period. Futura is working proactively with the FDA to confirm design of the new clinical trial. A third pre-submission meeting with the FDA is scheduled before the end of October and ahead of the commencement of any additional study to gain FDA’s clearance before proceeding with the study.
The company has been advised by its regulatory consultants that the FDA’s preference is to adopt an interactive approach to data requirements with its clients wherever possible ahead of regulatory submissions.
* Subject to the outcome from the follow up meeting with FDA regarding clinical data sufficiency
** Following the FM57 results the open label phase was discontinued prematurely and is no longer active