Eroxon® is the branded name used by a number of distributors, whereas MED3000 is the codename used by Futura during the product development. The use of Eroxon® as a brand name will nevertheless will be dependent on a country-by-country basis and on a number of factors, such as regulatory approval, which may be outside the control of Futura or the distributor.
Eroxon®, our lead product was developed specifically for the treatment of erectile dysfunction (“ED”). Eroxon® 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.
Eroxon® is a topical gel applied directly to the head (glans) of the penis for the treatment of ED.
Eroxon® works through a unique evaporative mode of action. Eroxon®’s combination of volatile components creates a novel cooling and recovery warming 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 Eroxon® in the trials were minimal: 3% of men reported a headache, significantly fewer than associated with the PDE5i’s, 1% of men reported a ‘localised burning sensation’ and 1.3% of partners reported a headache.
Eroxon® is for use in men who experience ED. It should not be used by those who do not have problems with ED.
No, 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 and other pharmacies and retailers. Eroxon® is also available online in Italy, France and Spain and in the United Arab Emirates.
Eroxon® launched in April in the UK and was initially available on boots.com and in store. It is also now available in other pharmacies and retailers across the UK.
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 Eroxon® as a medical device is endorsed by both EU and US regulatory authorities In 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, MED3000 was granted marketing authorisation by the US FDA for over the counter sale.
Eroxon® became available in the UK and in Belgium online and in store in April 2023 and has since become available online in Italy, France and Spain. Further online and retail launches supported by advertising and promotion are expected over the coming months.
Futura's breakthrough, topical gel formulation Eroxon® will become the first pan-European topical treatment for erectile dysfunction ("ED") available without the need of a doctor's prescription.
Eroxon® became available in the UK and in Belgium online and in store in April 2023 and has since become available online in Italy, France and Spain with more countries to follow. On 18 April, Eroxon® became available on boots.com and in store in the UK. It is also now available in other pharmacies and retailers in the UK.
Launch within the United Arab Emirates also commenced at the beginning of Q4 2023.
Further launches are planned throughout the remainder of 2023 and beyond.
MED3000 received the US Food and Drug Administration marketing authorisation as an OTC product on 9 June 2023 as a De Novo medical device.
On 17 July 2023, Futura Medical announced that it had entered into a ground breaking licensing agreement with Haleon plc ("Haleon"), a world leading consumer healthcare Company for the rights to exclusively commercialise the Company's innovative topical, gel-based Erectile Dysfunction ("ED") treatment MED3000, in the USA. Haleon is responsible for the future launch and ongoing regulatory, development, marketing, and commercialisation of MED3000 in the USA. Further details will be disclosed in due course.
MED3000 has been granted marketing authorisation in a growing number of countries across the world which now include Mexico, six countries in the Middle East (including Saudi Arabia) and Australia.
Futura has signed commercial deals across the world covering Europe, the USA, Central and South America, the Middle East and South Korea with the first launch outside of Europe, in the United Arab Emirates, having commenced at the beginning of Q4, 2023 with further launches expected over the coming months:
August 2021: m8 Pharmaceuticals to commercialise MED3000 in Brazil and Mexico, which was expanded in November 2023 to a further fourteen countries covering the Central and South American region.
September 2021: Labatec Pharma to commercialise MED3000 in the Gulf and Middle East Region.
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.
In 2023, Futura signed or expanded the following commercial deals:
July 2023: Haleon to exclusively commercialise MED3000 in the USA.
November 2023: Futura expands partnership with M8 Pharmaceuticals.
All distribution will be handled by our appointed distribution partners and retailers. Eroxon® 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 is accompanied by a leaflet, containing warnings and precautions and recommending users have a check-up with their doctor as soon as possible within the first 6 months of using MED3000 to ensure that their erection problems are not caused by another serious health condition.
We have not conducted studies on Eroxon® in combination with PDE5i’s. 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.
We have a shelf life of 3 years.
It is currently being sold in the UK in Boots for £24.99 for 4 single use applications.