MED3000, our lead product, is a topical gel which utilises our proprietary technology DermaSys®, developed specifically for the treatment of erectile dysfunction (“ED”). MED3000 is a fast-acting topical treatment which has the potential to be a highly differentiated product by addressing significant unmet needs in the ED market.
MED3000 is the codename for a formulation of DermaSys® developed specifically for the treatment of ED. MED3000 is a unique formulation of DermaSys® using volatile and non-volatile 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.
Registration of MED3000 as a medical device is endorsed by both EU and US regulatory authorities. and is potentially a fast track and lower cost route to market. On Friday 30th April the Company announced that it has now received its MDR EU Quality Management Certificate for the placing on the market of a Class II(b) medical device known as MED3000 (“CE mark approval as a Class II(b) Medical Device, the product can have unrestricted sale (“OTC”)”).
The Company is filing for approval in USA as a De Novo medical device in 2022. As the drug-free formulation is regarded as low risk, free sale (OTC) designation is anticipated.
On Friday 30th April the Company announced that it has now received its MDR EU Quality Management Certificate for the placing on the market of a Class II(b) medical device known as MED3000 (“CE mark approval”).
The approval of MED3000 from the EU Notified Body paves the way for rapid approval in many countries around the world, including in the Middle East, Africa, the Far East Latin American regions which allow “fast-track” review based on recognition of the EU CE mark. Due to post-Brexit arrangements, the EU CE mark can be used to market the product in Great Britain until 30 June 2023 by which time a specific UKCA mark has to be obtained. This will be a streamlined process since it is understood the UK application can bridge to the EU approval.
Futura has retained specialist corporate advisers to assist the company in the appointment of world-wide distribution partners. Once appointed all marketing and marketing aspects of MED3000 including launch will be handled by them. Futura's breakthrough, topical gel formulation MED3000 will become the first pan-European topical treatment for erectile dysfunction ("ED") available without the need of a doctor's prescription.
MED3000 is currently not available for purchase.
On Friday 30th April the Company announced that it has now received its MDR EU Quality Management Certificate for the placing on the market of a Class II(b) medical device known as MED3000 (“CE mark approval”). The approval of MED3000 from the EU Notified Body paves the way for rapid approval in many countries around the world, including in the Middle East, Africa, the Far East and Latin American regions which allow “fast-track” review based on recognition of the EU CE mark. Due to post-Brexit arrangements, the EU CE mark can be used to market the product in Great Britain until 30 June 2023 by which time a specific UKCA mark has to be obtained. This will be a streamlined process since it is understood the UK application can bridge to the EU approval.
Futura is also in discussions to out-license the marketing and distribution rights of MED3000 for the UK, as well as other countries and once agreed all distribution will be handled by them.
In March 2020, Futura announced that it had received official minutes from the US Food and Drug Administration (FDA) for MED3000, the Company’s breakthrough fast acting clinically proven treatment for erectile dysfunction (“ED”), following its 4th Pre-Submission Meeting on 1st February 2021.
The minutes signify agreement between the FDA and Futura on the detailed clinical study design (protocol) for the small confirmatory clinical study, FM71, to be conducted prior to formal regulatory submission as a De Novo Medical Device. Detailed planning for the commencement of FM71 has now begun with first patient dosing expected H2 2021. The company currently expects submission for marketing authorisation within the USA to be made during H2 2022 with approval as soon as practicable thereafter.
The approval of MED3000 from the EU Notified Body (as announced on Friday 30th April) paves the way for rapid approval in many countries around the world, including in the Middle East, Africa, the Far East Latin American and Australia regions which allow “fast-track” review based on recognition of the EU CE mark. Due to post-Brexit arrangements, the EU CE mark can be used to market the product in Great Britain until 30 June 2023 by which time a specific UKCA mark has to be obtained. This will be a streamlined process since it is understood the UK application can bridge to the EU approval. Depending on the country these approvals are likely to take between 6 and 12 months from the time of submission.
Futura has retained specialist corporate advisers to assist the company in the appointment of world-wide distribution partners. Once appointed all marketing and distribution aspects of MED3000 (including any samples they may choose to provide) will be handled by them.
As mentioned in the March 2021 RNS, the Company confirmed that it had received official minutes from the US FDA, following its 4th Pre-Submission Meeting on 1st February 2021.
The minutes signify agreement between the FDA and Futura on the detailed clinical study design (protocol) for the small confirmatory clinical study, FM71, to be conducted prior to formal regulatory submission as a De Novo Medical Device. Detailed planning for the commencement of FM71 has now begun with first patient dosing expected H2 2021.
FM71 is designed to provide supplementary efficacy data to the previously reported FM57 study with a "least burdensome" approach and modest cost. Whilst the overall design is similar to that of the previous large phase 3 FM57 study that recruited approximately 1000 patients, no placebo (sham) cohort is required, hence the study is relatively small in size with approximately 100 patients.
FM71 will be a 6 month (24 weeks) duration study versus FM57 which was conducted over 3 months (12 weeks) to reassure the FDA that the efficacy does not diminish over a longer period of time. It is Futura's belief that this is unlikely as in the FM57 study efficacy improved from the first to third month of patient use. Two co-primary endpoints will measure change from baseline and whether this change is clinically important, both criteria being achieved in FM57 over the 12 week duration of the study Secondary endpoints include an agreed measure of speed of onset, a key differentiating claim, where FM57 showed that 60% of subjects noticed an erection within 10 minutes.
The Company has agreed with the FDA to include tadalafil (the active in Cialis®) at the lowest approved dose for on-demand use (5mg) for comparative purposes only on safety, speed of onset and efficacy; non-inferiority is not required to be shown.
FM71 is designed as a phase 3, multicentre, comparative, randomised, open-label, home use, parallel group study. The recruited patients will include those suffering from mild, moderate or severe ED, using either MED3000 or tadalafil 5mg (50 subjects per group) and will include 20 African American patients (from a US medical centre) and 80 patients recruited from Eastern Europe where sites include some of the same centres used in the FM57 study.
Per the regulatory update on 22nd March 2021, the Company is pleased to confirm that it has received official minutes from the FDA, following its 4th Pre-Submission Meeting held 1st February 2021.
The minutes signify agreement between the FDA and Futura on the detailed clinical study design (protocol) for the small confirmatory clinical study, FM71, to be conducted prior to formal regulatory submission as a De Novo Medical Device.
Detailed planning for the commencement of FM71 has now begun with first patient dosing expected H2 2021.
Patients interested in participating will be able to find details in due course on clinicaltrials.gov.
At this time we have not tested the product in patients who have undergone radical prostatectomy although the product has been shown to be effective in mild, moderate and severe ED of mixed causes.
If you have a medical condition you may need to speak to a doctor to discuss your condition to see if the product is suitable for you to use.
MED3000 will come with a leaflet part of which will cover warning and precautions and recommend users have a check-up with your doctor as soon as possible within the first 6 months of using MED3000 to ensure that any erection problems are not caused by another serious health condition.
We anticipate an initial shelf life of 2 years, extended to 3 years when the company generate longer term data.