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 The Company anticipates certification and CE marking in Europe by end May 2021 as a Class II(b) medical device, and 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.
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 any samples they may choose to provide) will be handled by them.
MED3000 is currently not available for purchase.
European approval for MED3000 will be final upon issuance of a Medical Device Regulation certificate by the EU Notified Body which is expected before the end of May 2021. 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 the EU Notified Body had successfully completed its review of the Company's Technical Dossier for MED3000 with a recommendation to certify MED3000 as a Class 2B approved medical device. European approval for MED3000 will be final upon issuance of a Medical Device Regulation certificate by the Notified Body which is expected before the end of May.
[A Notified Body is an organisation designated by EU regulators to assess the conformity of medical devices before being placed on the market.]
Once the certificate is received, 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.
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.
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.
European approval for MED3000 will be final upon issuance of a Medical Device Regulation certificate by the EU Notified Body which is expected before the end of May.
Once EU certification and the resultant CE mark is granted, this paves the way for rapid approval in many countries around the world in regions including the Middle East, Africa, the Far East and Latin America, who allow "fast-track" review based on their recognition of the EU CE mark. Depending on the country these approvals are likely to take between 6 and 12 months from the time of submission.
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 (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 a shelf life of 3 years.