Loading animation
  • Home
  • About us View About us's child pages
    • Who we are
    • Our business model
    • Our strategy
    • Board of Directors
  • What we do View What we do's child pages
    • Our technology
    • Our product development pipeline
    • MED3000 View MED3000's child pages
      • MED3000 Overview
      • MED3000 Clinical Programme
      • MED3000 Commercial potential
    • Pain Relief View Pain Relief's child pages
      • CBD100
      • TPR100 Clinical Data
      • TPR100 Commercial potential
    • Products FAQ's View Products FAQ's's child pages
      • MED3000 FAQs
      • FM71
      • CBD100 FAQs
      • DermaSys® FAQs
      • TPR100 FAQs
  • Investor centre View Investor centre's child pages
    • Share price chart
    • Corporate documentation
    • Videos and webcasts View Videos and webcasts's child pages
      • Videos
      • Webcasts
    • RNS
    • Alert service
    • Shareholder centre View Shareholder centre's child pages
      • Investor contacts and advisors
      • Shareholder information
      • Financial calendar
      • Investor FAQs
      • Analyst Research
    • Corporate Governance
    • AIM rule 26
  • Media View Media's child pages
    • News
    • Event calendar
    • RNS
    • Videos
    • Alert service
  • Contact us

Please use the arrows to navigate to the sub pages

  • About us View About us's child pages

    About us

    Futura Medical is a pharmaceutical company developing a portfolio of innovative products based on our proprietary, transdermal DermaSys® technology.

    Explore this section
    • Who we are
    • Our business model
    • Our strategy
    • Board of Directors
  • What we do View What we do's child pages

    What we do

    Futura Medical is developing a portfolio of innovative products for two large markets, sexual health and pain.

    Explore this section
    • Our technology
    • Our product development pipeline
    • MED3000 View MED3000's child pages

      MED3000

      • MED3000 Overview
      • MED3000 Clinical Programme
      • MED3000 Commercial potential
    • Pain Relief View Pain Relief's child pages

      Pain Relief

      • CBD100
      • TPR100 Clinical Data
      • TPR100 Commercial potential
    • Products FAQ's View Products FAQ's's child pages

      Products FAQ's

      • MED3000 FAQs
      • FM71
      • CBD100 FAQs
      • DermaSys® FAQs
      • TPR100 FAQs
  • Investor centre View Investor centre's child pages

    Investor centre

    Futura has a proven track record in delivery and completion of Research & Development projects up to value inflection points at which they are suitable for commercialisation partners.

    WEBCASTS

    Explore this section
    • Share price chart
    • Corporate documentation
    • Videos and webcasts View Videos and webcasts's child pages

      Videos and webcasts

      • Videos
      • Webcasts
    • RNS
    • Alert service
    • Shareholder centre View Shareholder centre's child pages

      Shareholder centre

      • Investor contacts and advisors
      • Shareholder information
      • Financial calendar
      • Investor FAQs
      • Analyst Research
    • Corporate Governance
    • AIM rule 26
  • Media View Media's child pages

    Media

    This section contains the latest RNS, news and videos.

    Explore this section
    • News
    • Event calendar
    • RNS
    • Videos
    • Alert service
  • Contact us
  • About us View About us's child pages
    • Who we are
    • Our business model
    • Our strategy
    • Board of Directors
  • What we do View What we do's child pages
    • Our technology
    • Our product development pipeline
    • MED3000 View MED3000's child pages
      • MED3000 Overview
      • MED3000 Clinical Programme
      • MED3000 Commercial potential
    • Pain Relief View Pain Relief's child pages
      • CBD100
      • TPR100 Clinical Data
      • TPR100 Commercial potential
    • Products FAQ's View Products FAQ's's child pages
      • MED3000 FAQs
      • FM71
      • CBD100 FAQs
      • DermaSys® FAQs
      • TPR100 FAQs
  • Investor centre View Investor centre's child pages
    • Share price chart
    • Corporate documentation
    • Videos and webcasts View Videos and webcasts's child pages
      • Videos
      • Webcasts
    • RNS
    • Alert service
    • Shareholder centre View Shareholder centre's child pages
      • Investor contacts and advisors
      • Shareholder information
      • Financial calendar
      • Investor FAQs
      • Analyst Research
    • Corporate Governance
    • AIM rule 26
  • Media View Media's child pages
    • News
    • Event calendar
    • RNS
    • Videos
    • Alert service
  • Contact us
    Smiling couple hugging

    MED3000 FAQs

    • Home
    • What we do
    • Products FAQ's
    • MED3000 FAQs

    • What is the difference between Eroxon® and MED3000?

      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.

       

    • What is MED3000?

      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.

    • How does MED3000 work?

      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.

       

    • What evidence do you have that MED3000 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.

    • Are there any side-effects with MED3000?

      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’.

    • Can people who do not suffer from ED use MED3000?

      MED3000 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 for MED3000?

      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.

    • When will Eroxon® be available in local pharmacies in the UK?

      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.

    • What is the regulatory pathway for a medical device? Why has Futura decided to go down this route?

      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.

    • When will MED3000 be on the market in the EU?

      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.

    • How can I buy MED3000? Is MED3000 available for purchase?

      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.

    • When will MED3000 be on the market in the US?

      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.

    • When will MED3000 be on the market in the rest of the world?

      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.

       

       

    • Will you be supplying samples to shareholders?

      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.

       

    • Will MED3000 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 MED3000 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 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.

    • When MED3000 launches what do you expect will be the shelf life?

      We anticipate an initial shelf life of 2 years, extended to 3 years when the company generate longer term data.

    • How much will the product sell for? Will there be a consistent price globally?

      It is being sold in the UK for £24.99 for 4 single use applications.

    • What if MED3000 is used in combination with PDE5is? Will post-approval studies be necessary?

      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

    You may also be interested in

    MED3000 Overview
    MED3000 Clinical Programme
    MED3000 Commercial potential
    Futura Medical logo

    ©2023 Futura Medical

    • Sitemap
    • Contact us
    • Accessibility
    • Terms of use
    • Privacy & cookies policies

    Designed and developed by
    jonesandpalmer.co.uk