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