What is the difference between Eroxon® and MED3000?
Eroxon® is the brand name used by a number of distributors whereas MED3000 was the codename used by Futura during the product development phase. The use of Eroxon® as a brand name may vary country to country dependent on a number of factors, such as regulatory approval and the local trademark situation which may be outside the control of Futura or the distributor.
What is Eroxon®?
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.
How does Eroxon® work?
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.
What evidence do you have that Eroxon® works?
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. Our commercial partners have also independently conducted four “home-use” studies with over 600 users to validate the strength of the proposition. This has confirmed results that are aligned with the Eroxon® clinical efficacy data (>60% success rate) providing real world evidence.
Are there any side-effects with Eroxon®?
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.
Can people who do not suffer from ED use Eroxon®?
Eroxon® is for use in men who experience ED. It should not be used by those who do not have problems with ED.
Do you need a prescription to buy Eroxon® in the UK?
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, and is available in many pharmacy and retail stores across the UK..
As well as being available without a doctor’s prescription (‘over the counter’), Eroxon®, is also available on prescription in England and Wales for the treatment of erectile dysfunction since the 1st of March 2024.
Eroxon® is also available online and in retailers across a number of countries in Europe and the rest of the world with further launches planned. For more information on the go-to-market progress of Eroxon® click here and on the commercialisation of Eroxon® click here.
When will Eroxon® be available in local pharmacies in the UK?
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.
What is a medical device? What is the approval status of Eroxon® across the world ?
The definition of a medical device includes products which are used in the treatment of illness or disease but which do not achieve their principal intended action on the human body by pharmacological, immunological or metabolic means. Medical devices are subject to stringent regulations to establish safety and effectiveness.
Approval of Eroxon® as a medical device clinically proven to treat erectile dysfunction has been granted in both the USA and EU as well as a growing number of other countries across the world.
Is Eroxon® available in the EU?
Eroxon® became available in the UK and in Belgium online and in store in April 2023.
Eroxon® has since launched in the key European markets of France, Italy and Spain as well as other European markets, both online and in retail stores, supported by advertising and promotion.
Futura's breakthrough, topical gel formulation Eroxon® is the first pan-European topical treatment for erectile dysfunction ("ED") available without the need of a doctor's prescription.
How can I buy Eroxon®? Where is Eroxon® available for purchase?
Eroxon® is available to purchase online and in retail stores across a growing number of markets across the world. Further details can be found online at www.eroxon.com.
When will Eroxon® be on the market in the US?
Eroxon® received US Food and Drug Administration (FDA) marketing authorisation as an OTC product on 9 June 2023 as a De Novo medical device.
In 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 Eroxon®, in the USA. Haleon is responsible for the launch and ongoing regulatory, development, marketing, and commercialisation of Eroxon® in the USA.
Following detailed preparation work alongside Haleon ahead of the launch, Eroxon® will be available to purchase in the US from October 2024.
When will Eroxon® be on the market in the rest of the world?
Eroxon® has been granted marketing authorisation in a growing number of countries across the world.
Futura has signed commercial deals across the world covering Europe, the USA, Central and South America, the Middle East and South Korea. Launches commenced in 2023 and are expected to continue throughout 2024 and into 2025.
August 2021: M8 Pharmaceuticals to commercialise Eroxon® 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 Eroxon® in the Gulf and Middle East Region.
May 2022: Cooper Consumer Health to commercialise Eroxon® 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 Eroxon® in the USA.
November 2023: Futura expands partnership with M8 Pharmaceuticals.
August 2024: M8 launches Eroxon® in Mexico, the first Latin American country where the product has gone on sale.
September 2024: Haleon confirms Eroxon® will be available in the US from October 2024.
Will you be supplying samples to shareholders?
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.
Will Eroxon® work if I have had a prostatectomy?
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.
Can I use Eroxon® if I have a medical condition?
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.
What if Eroxon® is used in combination with PDE5is? Will post-approval studies be necessary?
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.
When Eroxon® launches what do you expect will be the shelf life?
We have a shelf life of 3 years.
How much will the product sell for? Will there be a consistent price globally?
It is currently being sold in the UK in Boots for £24.99 for 4 single use applications.