MED3000 FAQs

MED3000 is now the codename for a formulation of DermaSys^® developed specifically for the treatment of ED. MED3000 is a unique formulation of DermaSys^® using volatile solvent components tailored for the treatment of ED.

MED3000 is a topical gel applied directly to the head (glans) of the penis for the treatment of 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.

A medical device is described within the EU as a product which does not achieve its principal intended action on the human body by pharmacological, immunological or metabolic means.  

These regulatory positions are the consensus from a number of regulatory experts consulted by Futura.  The Company is making progress with filing MED3000 for approval as a medical device in both Europe and the United States.

Unfortunately, under the current regulations, Futura Medical are not able to provide samples.

In Europe the Company submitted the Technical Dossier on MED3000 for review to the designated European Notified Body as announced on 14th July 2020. [A Notified Body is an organisation designated by EU regulators to assess the conformity of medical devices before being placed on the market.] In parallel, as announced in 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. Futura continues to target a 2021 European approval date.

In the USA, arising from a second pre-submission meeting in July 2020 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 US FDA to confirm design of the new clinical trial to provide the necessary reassurance of MED3000's efficacy for up to six months and progress the OTC label and leaflet development.

This requirement to run a small confirmatory study of 6 month’s duration in addition to the completed large pivotal study, FM57 is significantly less burdensome than two large pivotal studies that would have been required as a drug product as opposed to a medical device. Final clearance from FDA on the scope and design of the additional study will allow Futura to determine its expected cost and the study will not start until that clearance is received. 

In Europe the Company submitted the Technical Dossier on MED3000 for review to the designated European Notified Body as announced on 14th July 2020. [A Notified Body is an organisation designated by EU regulators to assess the conformity of medical devices before being placed on the market.] In parallel, as announced in 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. Futura continues to target a 2021 European approval date.

In the USA, arising from a second pre-submission meeting in July 2020 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 US FDA to confirm design of the new clinical trial to provide the necessary reassurance of MED3000's efficacy for up to six months and progress the OTC label and leaflet development.

This requirement to run a small confirmatory study of 6 month’s duration in addition to the completed large pivotal study, FM57 is significantly less burdensome than two large pivotal studies that would have been required as a drug product as opposed to a medical device. Final clearance from FDA on the scope and design of the additional study will allow Futura to determine its expected cost and the study will not start until that clearance is received. 

Currently there are no requirements for patients in clinical trials however as per the regulatory update on 22^nd October 2020, the Company is pleased to confirm that following its third pre-submission meeting with FDA, there was preliminary agreement on the design and scope of a small supplementary study, known as "FM71" subject to the issue of the final meeting minutes. Detailed planning for the study has now commenced and Futura is targeting Q1 2021 patient enrolment depending on completion of the final study protocol for FM71.

Patients interested in participating will be able to find details in due course on clinicaltrials.gov.

The DermaSys^® control (now known as MED3000) showed very high levels of efficacy in mild, moderate and severe ED. The vast majority of subjects experienced a meaningful clinical improvement in their ED; up to 83%. This left limited ability to show additional improvement for MED2005.

All four formulations tested; the Dermasys^® control (now known as MED3000) and the 3 formulations containing the active ingredient in the Dermasys^® base, showed very high levels of efficacy in mild, moderate and severe ED when compared to the pre-treatment (baseline) level of ED. However, because the vast majority of subjects experienced a meaningful clinical improvement, up to 83%, with the  Dermasys^® control. This left limited ability to show additional improvement for MED2005.

An ED-specific DermaSys^® formulation (now known as MED3000) was used as a control arm (placebo) following regulatory requirements, including the FDA in the US. The documented code requirement here is that the placebo must be as identical as possible to the test product. With respect to physical characteristics, placebos must have identical smell, colour, physical sensation on the skin to enable studies to be authentically blinded, disabling the patient from determining which is the drug and which is the placebo. The FDA acknowledge that not all placebos are inactive and to meet their requirements it was agreed in consultation with them that only the DermaSys^® base would be appropriate.

The Phase 2 study did show a placebo effect which was expected as the massaging of gel into the glans penis will cause some sexual stimulation. However, the effect was much lower than experienced in the phase 3 study. We believe the greater effectiveness in the Phase 3 study is a result of two main factors.

1. The study had far greater scale than the Phase 2 study. The study ran for 12 weeks versus 4 weeks where we noticed improvement in efficacy between 4 and 12 weeks. Also 61 sites were used versus 4 sites in the phase 2 study which would reduce the impact of natural variability occurring between test sites. Moreover, 3792 versus 984 intercourse attempts were made which is a much larger and more reliable sample size to study the effect.
2. We learnt from the Phase 2 study that enhancements to the subject recruitment process and pre-screening were required and therefore much greater emphasis on this was placed in the Phase 3 study with very strict compliance to the inclusion and exclusion criteria. We also placed greater emphasis on patient training and therefore compliance to the treatment regimen.

Therefore, we have concluded that in moving from a small Phase 2 study to a large Phase 3 study that the placebo effect was far greater than first indicated and presents an exciting opportunity in its own right without the inclusion of a drug substance.

As mentioned in the July 2020 RNS, the next steps will be to confirm design of the new clinical trial with FDA to provide the necessary reassurance of MED3000's efficacy for up to six months and progress the OTC label and leaflet development. The requirement of FDA for Futura to run a small confirmatory study of 6 months' duration in addition to the completed large pivotal study, FM57 is significantly less burdensome in the Board's view than two large pivotal studies of 12 and 3 months' duration that would have been required as a drug product as opposed to a medical device.