Eroxon® is the branded name expected to be used with a number of distributors whereas MED3000 which is the codename used by Futura during MED3000’s development. The use of Eroxon® nevertheless will be dependent from country to country dependent on a number of factors, such as regulatory approval, which may be outside the control of Futura or the distributor.
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 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.
The efficacy of Eroxon® has been demonstrated in two Phase 3 trials in 300 men with mild, moderate, and severe ED, which investigated improvement in their erectile function compared with baseline.
Reported side effects of MED3000 in the trials were minimal: 3% of men reported headache, significantly fewer than associated with the PDE5i’s. 1% of men and 0.4% of their female partners reported a ‘localised burning sensation’.
MED3000 is for use in men who experience ED. It should not be used by those who do not have problems with ED.
No, MED3000, under the brand name Eroxon, is the first clinically proven topical therapy for erectile dysfunction that can be bought in the UK without the need for a prescription, over the counter at Boots and Boots.com.
Eroxon® launched on the 18 April in the UK and will initially be available on boots.com and in store. Other pharmacies are expected in the near future.
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 2021, 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”).
In 2022, Futura received approval for a UKCA mark for MED3000, supplementing the CE Mark approval received in April 2021.
In June 2023, Futura was granted Marketing Authorisation by the US Food and Drug Administration ("FDA") for the Over the Counter (“OTC”) sale of MED3000.
In March 2023, Eroxon™ became available online in the Benelux region and in retail pharmacies across Belgium. Further online and retail launches are expected over the coming months.
In April 2021 the Company announced that it received its MDR EU Quality Management Certificate for the placing on the market of a Class 2B medical device known as MED3000 ("CE mark approval"). Futura's breakthrough, fast acting topical gel formulation MED3000, is the first clinically proven, pan-European topical treatment for adult men with ED available without a doctor's prescription ("OTC").
The CE mark approval of MED3000 from the EU Notified Body1 paves the way for approval in many countries around the world, including in the Middle East, Africa and the Far East 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.
In 2022, Futura received approval for a UKCA mark for MED3000, supplementing the CE Mark approval received in April 2021.
Futura has retained specialist corporate advisers to assist the company in the appointment of world-wide distribution partners. All distribution 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.
Note
¹Notified Bodies are organizations designated by EU countries to oversee the approval of medical devices within the EU and the UK.
In March 2023, Eroxon™ became available online in the Benelux region and retail pharmacies in Belgium. On the 18 April, Eroxon™ became available on boots.com and in store. Further online and retail launches are expected over the coming months.
MED3000 received the US Food and Drug Administration grant of approval for Over The Counter (OTC) Marketing Authorisation on the 12 June 2023 as a medical device. Futura has commenced the search for a US commercial partner and continues to be engaged in a number of ongoing discussions.
The approval of MED3000 from the EU Notified Body (as announced on Friday 30th April 2021) 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.
In 2021 Futura signed three commercial deals:
March 2021: Co-High Investment Management to commercialise MED3000 in China and South East Asia.
August 2021: m8 Pharmaceuticals to commercialise MED3000 in Brazil and Mexico.
September 2021: Labatec Pharma to commercialise MED30 00 in the Gulf and Middle East Region.
In 2022, Futura entered into the following commercial deals:
March 2022: A. Menarini Korea Limited for the exclusive rights to MED3000 in South Korea.
May 2022: Cooper Consumer Health to commercialise MED3000 throughout the European Economic Area, United Kingdom and Switzerland.
All distribution will be handled by our appointed distribution partners and retailers. MED3000 addresses the significant and specific medical needs of men who suffer from erectile dysfunction and its use, where approved to be a treatment without the need for a doctor’s prescription, will require careful consideration by the patient in terms of self-diagnosis and use according to product label information.
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.
It is being sold in the UK for £24.99 for 4 single use applications.
We have not conducted studies on MED3000 in combination with PDE5i’s and it is not included on our proposed label. It is likely that a post-approval study will be needed to demonstrate synergy. We do not anticipate any safety issues in combining the two treatments Regulatory status in other geographies, especially where there are commercialisation agreements in place e.g. China, LatAm, Gulf States
FM71 is a multi-centre, randomised, open-label, home use, parallel group, clinical investigation of topically-applied MED3000 gel compared to oral tadalafil (5mg) tablets for the treatment of ED 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 which we continue to target filing by the end of September 2022.
FM71 investigated the efficacy and safety of MED3000 gel in 96 male patients clinically diagnosed with a mix of mild, moderate and severe ED against baseline (pre-treatment). Subjects were recruited from United States (African Americans), Poland, Georgia and Bulgaria and included men who had organic and psychological ED or a combination of both.
Patients 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.
Further information can be found in the FM71 study results press release here, and the FM71 study results webcast here
Tadalafil was chosen as a control product at the original suggestion of FDA. We agreed with the choice as it represents a widely used marketed product in the USA. After discussion with FDA, they agreed that we could use the lowest effective and approved dose in the USA (5mg). As indicated above, the purpose of including and assessing relative efficacy and safety is to help FDA determine the benefit risk ratio for MED3000 against a marketed control. It is not a pre-requisite for success in the study that we match the efficacy of tadalafil.
Unlike MED3000, oral tadalafil failed to meet the criteria agreed with FDA to demonstrate onset of action within 10 minutes. Oral tablets typically take 30-60 minutes to work.
In September 2022, Futura announced positive results from the confirmatory Phase 3 clinical study, “FM71” for MED3000, for the treatment of erectile dysfunction.
MED3000 presents an effective clinically proven treatment for erectile dysfunction (“ED”) with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for Over the Counter (“OTC”) classification1
Futura filed a dossier with the US FDA in October 2022, targeting marketing authorisation by the FDA of MED3000 in Q2 2023 as the first major ED treatment available OTC throughout the USA.
Further information can be found in the FM71 study results press release here, and the FM71 study results webcast here
“Clinically proven gel to treat erectile dysfunction” and “Helps you get an erection within 10 minutes” are the approved EU and UK claims. These claims are subject to ratification by FDA.
CBDerma Technology is a company that has been established with backers that have experience in plant derived products. Futura announced a joint venture collaboration with CBDerma Technology Limited in September 2019 to explore the application of Futura’s advanced proprietary transdermal technology, DermaSys® for the delivery of cannabidiol.
The cosmetic market is already significant with the UK, we understand, over £300 million. As a topically applied Pharmaceutical the potential is huge but under-explored so far, with currently very little credible scientific research conducted on topical formulations.
DermaSys® provides rapid and targeted local delivery of active pharmaceutical ingredients (API) at therapeutic levels and Generally Recognized As Safe (GRAS) pharmaceutical excipients onto and through the skin to the required site of action with a high level of safety. It is a versatile and bespoke technology that can be tailored to suit the specific active compound being used and the therapeutic indication. Each product is formulated to maximise its benefits for patients and consumers and can be developed for the prescription and consumer healthcare markets as appropriate.
Our transdermal technology DermaSys® is tailored for each product to suit the specific therapeutic indication and desired speed of onset and duration of action offering improvements over existing products creating novel indications with compelling commercial potential. This means that our products are highly differentiated in their markets whilst avoiding the risks normally associated with the development of new molecules.
CBD100 comprises a unique combination of penetration enhancers components and a diffusion enhancer. It is designed to provide highly efficient penetration of cannabidiol into and through the skin with a stability expected to ensure potency is retained during shelf-life.
A patent application was filed in the UK in August 2020.
We would expect to receive an initial search report on the ‘patentability’ of such application within six months. This will provide details of other patents or application already in existence which may affect the novelty and inventiveness of any new application. This may result in some amendment to the patent application ahead of a PCT application next July.
We are aiming for CBD100 to be highly differentiated from existing, largely un-regulated, low-tech products in the fast growing cannabidiol market on the basis of quality, stability and efficient delivery to the skin for a number of applications and indications expected to range from cosmeceutical through to pharmaceutical dermal and pain relief treatments. We have now started to explore commercialisation options for CBD100 with CBDerma as stability work continues in parallel. These options will also be influenced by the regulatory landscape around Cannabis which continues to evolve in the EU and USA.
Unfortunately, under the current regulations, Futura Medical are not able to provide samples.
Futura’s unique transdermal technology DermaSys® enables targeted and rapid delivery of clinically proven effective medical treatments through the skin.
Our transdermal technology DermaSys® is tailored for each product to suit the specific therapeutic indication and desired speed of onset and duration of action offering improvements over existing products creating novel indications with compelling commercial potential. This means that our products are highly differentiated in their markets while avoiding the risks normally associated with the development of new molecules.
DermaSys® is a versatile normally clear, odourless gel uniquely formulated using permeation and penetration enhancer components tailored for each product, to suit the specific therapeutic indication and desired speed of onset and duration of action. Each product is formulated to maximise its benefits for patients and consumers.
DermaSys® is a proprietary transdermal technology platform with very strong IP offering a high level of product differentiation compared to existing marketed treatments. Each new unique formulation offers the opportunity for additional patent applications and potential patent protection.
In February 2019, the UK Medicines and Healthcare products Regulatory Agency (MHRA) responded to Thornton & Ross’s marketing authorisation application filed in July 2018, raising a number of questions requiring additional laboratory work specifically around the permeation characteristics of TPR100 to be conducted. The additional lab work has been completed indicating that absorption of TPR100 is significantly superior to the market leader. These results were discussed with MHRA in a Scientific Advice meeting and it was determined that as there was non-equivalency a clinical study was required. MHRA suggested that the clinical study could be used to support superiority claims for the formulation. Futura are determining how this study could be funded and used to support the product in markets around the world including the US where Voltaren (GSK) has recently achieved OTC designation.
Our transdermal technology DermaSys® is tailored for each product to suit the specific therapeutic indication and desired speed of onset and duration of action offering improvements over existing products creating novel indications with compelling commercial potential. This means that our products are highly differentiated in their markets whilst avoiding the risks normally associated with the development of new molecules.
The rapid skin permeation rate offered by our transdermal delivery system, DermaSys®, is ideally suited for targeted topical pain relief. Rapid, targeted and effective skin permeation offers potential benefits in pain management including: improved onset of action, duration and degree of pain relief.
TPR100 does not require a combination of volatile solvent components to stimulate nerve sensors. It is designed to provide a sustained mode of action suitable for the treatment of pain and is formulated with this objective in mind.
TPR100's current patent protection runs until February 2028 in the USA and Europe.