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

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

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    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.

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    DermaSys<sup>®</sup> FAQs

    • DermaSys® FAQs
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    • What is DermaSys®?

      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 volatile solvent component formulations 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.

       

    • What is the full IP position of DermaSys® Technology and all its formulations?

      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. Aside from our current patent lawyers, Futura recently retained a specialist biotech IP and strategic advice company to assist in maximising the robustness of the MED3000 intellectual property.  

    • 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.

    • What is the difference between MED2005 and MED3000?

      MED3000 is now the codename for a formulation of DermaSys® developed specifically for the treatment of ED. MED3000 is a unique formulation of DermaSys® using volatile solvent components tailored for the treatment of ED.

    • 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 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.  

      These regulatory positions are the consensus from a number of regulatory experts consulted by Futura.  The Company is making progress with filing MED3000 for approval as a medical device in both Europe and the United States.

    • Can I request a sample of MED3000?

      Unfortunately, under the current regulations, Futura Medical are not able to provide samples.

    • When will MED3000 be on the market?

      In Europe the Company submitted the Technical Dossier on MED3000 for review to the designated European Notified Body as announced on 14th July 2020. [A Notified Body is an organisation designated by EU regulators to assess the conformity of medical devices before being placed on the market.] In parallel, as announced in February 2020, the Company had been progressing the development of its Quality Management System (QMS) and in early August received a positive audit opinion from the Company’s designated Notified Body. These milestones pave the way for the Notified Body to complete its review of MED3000 under the new European Medical Device Regulations. Futura continues to target a 2021 European approval date.

      The company has provided a regulatory update on 22nd October 2020.  In the USA, Futura has continued to work proactively with the FDA to confirm the design of the requested supplemental clinical trial to provide the necessary reassurance of MED3000's efficacy for up to six months.  The Company's previous 1,000 patient study (FM57), which reported results in December 2019, met all its primary endpoints against a pre-treatment baseline and across all ED severities for efficacy for up to three months and also provided extensive safety reassurance. In addition, progress has been made around the label and leaflet development to enable the product to be approved by the FDA without the need of a doctor's prescription.

       The Company is pleased to confirm that following its third pre-submission meeting with FDA, there was preliminary agreement on the design and scope of this small supplementary study, known as "FM71" subject to the issue of the final meeting minutes. The final study protocol can only be completed once the FDA minutes have been received. However, based on the pre-submission discussions FM71 is expected to be a comparative, randomised, open label, home use, parallel group study in approximately 100 patients with erectile dysfunction. Approximately 20 subjects will be located in the United States to provide reassurance that data generated outside the US is comparable to the US population. As an open-label design the study will be neither placebo controlled nor double-blinded, the study's primary endpoint will be to compare MED3000 against a pre-treatment baseline for efficacy for up to six months. The lowest "on demand" dose of tadalafil, 5mg (Cialis) will also be measured against pre-treatment baseline to enable the FDA to compare an overall risk/benefit analysis of the two treatments for the 6 month period of the study looking at efficacy, speed of onset and safety. 50 patients with ED will be included in each treatment arm of the study.

      Detailed planning for the study has now commenced and Futura is targeting Q1 2021 patient enrolment depending on completion of the final study protocol for FM71.

    • When will MED3000 regulatory filings for marketing authorisation be made in Europe and USA?

      In Europe the Company submitted the Technical Dossier on MED3000 for review to the designated European Notified Body as announced on 14th July 2020. [A Notified Body is an organisation designated by EU regulators to assess the conformity of medical devices before being placed on the market.] In parallel, as announced in February 2020, the Company had been progressing the development of its Quality Management System (QMS) and in early August received a positive audit opinion from the Company’s designated Notified Body. These milestones pave the way for the Notified Body to complete its review of MED3000 under the new European Medical Device Regulations. Futura continues to target a 2021 European approval date.

      In the USA, as per the update on 22nd October, Futura has continued to work proactively with the FDA to confirm the design of the requested supplemental clinical trial to provide the necessary reassurance of MED3000's efficacy for up to six months.  The Company's previous 1,000 patient study (FM57), which reported results in December 2019, met all its primary endpoints against a pre-treatment baseline and across all ED severities for efficacy for up to three months and also provided extensive safety reassurance. In addition, progress has been made around the label and leaflet development to enable the product to be approved by the FDA without the need of a doctor's prescription.

       The Company is pleased to confirm that following its third pre-submission meeting with FDA, there was preliminary agreement on the design and scope of this small supplementary study, known as "FM71" subject to the issue of the final meeting minutes. The final study protocol can only be completed once the FDA minutes have been received. However, based on the pre-submission discussions FM71 is expected to be a comparative, randomised, open label, home use, parallel group study in approximately 100 patients with erectile dysfunction. Approximately 20 subjects will be located in the United States to provide reassurance that data generated outside the US is comparable to the US population. As an open-label design the study will be neither placebo controlled nor double-blinded, the study's primary endpoint will be to compare MED3000 against a pre-treatment baseline for efficacy for up to six months. The lowest "on demand" dose of tadalafil, 5mg (Cialis) will also be measured against pre-treatment baseline to enable the FDA to compare an overall risk/benefit analysis of the two treatments for the 6 month period of the study looking at efficacy, speed of onset and safety. 50 patients with ED will be included in each treatment arm of the study.

      Detailed planning for the study has now commenced and Futura is targeting Q1 2021 patient enrolment depending on completion of the final study protocol for FM71.

    • Can I participate in the MED3000 clinical trial/Can I try this product?/Can I become a test patient? How can I apply for the clinical trial?

      Currently there are no requirements for patients in clinical trials however as per the regulatory update on 22nd October 2020, the Company is pleased to confirm that following its third pre-submission meeting with FDA, there was preliminary agreement on the design and scope of a small supplementary study, known as "FM71" subject to the issue of the final meeting minutes. Detailed planning for the study has now commenced and Futura is targeting Q1 2021 patient enrolment depending on completion of the final study protocol for FM71.

      Patients interested in participating will be able to find details in due course on clinicaltrials.gov.

    • Why wasn’t MED2005 effective against Placebo ?

      The DermaSys® control (now known as MED3000) showed very high levels of efficacy in mild, moderate and severe ED. The vast majority of subjects experienced a meaningful clinical improvement in their ED; up to 83%. This left limited ability to show additional improvement for MED2005.

    • Why was no significant difference shown as a result of the active, in any formulation?

      All four formulations tested; the Dermasys® control (now known as MED3000) and the 3 formulations containing the active ingredient in the Dermasys® base, showed very high levels of efficacy in mild, moderate and severe ED when compared to the pre-treatment (baseline) level of ED. However, because the vast majority of subjects experienced a meaningful clinical improvement, up to 83%, with the  Dermasys® control. This left limited ability to show additional improvement for MED2005.

    • Why did you use DermaSys® as a placebo?

      An ED-specific DermaSys® formulation (now known as MED3000) was used as a control arm (placebo) following regulatory requirements, including the FDA in the US. The documented code requirement here is that the placebo must be as identical as possible to the test product. With respect to physical characteristics, placebos must have identical smell, colour, physical sensation on the skin to enable studies to be authentically blinded, disabling the patient from determining which is the drug and which is the placebo. The FDA acknowledge that not all placebos are inactive and to meet their requirements it was agreed in consultation with them that only the DermaSys® base would be appropriate.

    • Did the Phase 2 results show placebo effect?

      The Phase 2 study did show a placebo effect which was expected as the massaging of gel into the glans penis will cause some sexual stimulation. However, the effect was much lower than experienced in the phase 3 study. We believe the greater effectiveness in the Phase 3 study is a result of two main factors.

      1. The study had far greater scale than the Phase 2 study. The study ran for 12 weeks versus 4 weeks where we noticed improvement in efficacy between 4 and 12 weeks. Also 61 sites were used versus 4 sites in the phase 2 study which would reduce the impact of natural variability occurring between test sites. Moreover, 3792 versus 984 intercourse attempts were made which is a much larger and more reliable sample size to study the effect.
      2. We learnt from the Phase 2 study that enhancements to the subject recruitment process and pre-screening were required and therefore much greater emphasis on this was placed in the Phase 3 study with very strict compliance to the inclusion and exclusion criteria. We also placed greater emphasis on patient training and therefore compliance to the treatment regimen.

      Therefore, we have concluded that in moving from a small Phase 2 study to a large Phase 3 study that the placebo effect was far greater than first indicated and presents an exciting opportunity in its own right without the inclusion of a drug substance.

    • When is Futura Medical looking to start the new clinical trial?

      As mentioned in the July 2020 RNS, the next steps will be to confirm design of the new clinical trial with FDA to provide the necessary reassurance of MED3000's efficacy for up to six months' and progress the OTC label and leaflet development.

      As per the Company’s regulatory update on 22nd October 2020, following Futura’s third pre-submission meeting with FDA, there was preliminary agreement on the design and scope of this small supplementary study, known as "FM71" subject to the issue of the final meeting minutes. The final study protocol can only be completed once the FDA minutes have been received. However, based on the pre-submission discussions FM71 is expected to be a comparative, randomised, open label, home use, parallel group study in approximately 100 patients with erectile dysfunction. Approximately 20 subjects will be located in the United States to provide reassurance that data generated outside the US is comparable to the US population. As an open-label design the study will be neither placebo controlled nor double-blinded, the study's primary endpoint will be to compare MED3000 against a pre-treatment baseline for efficacy for up to six months. The lowest "on demand" dose of tadalafil, 5mg (Cialis) will also be measured against pre-treatment baseline to enable the FDA to compare an overall risk/benefit analysis of the two treatments for the 6 month period of the study looking at efficacy, speed of onset and safety. 50 patients with ED will be included in each treatment arm of the study.

      Detailed planning for the study has now commenced and Futura is targeting Q1 2021 patient enrolment depending on completion of the final study protocol for FM71.

    • What is the difference between Eroxon®, MED2002, MED2005 and MED3000?

      Eroxon® is the registered and suggested brand name for Futura’s topical gel for ED, though potential distributors may choose to use other brand names.

      MED3000 is now the codename for a formulation of DermaSys® developed specifically for the treatment of ED.

      MED2005 or MED2002 are the codenames used by Futura for all proprietary formulations containing Glyceryl Trinitrate (GTN).

    • How can I apply for the trial?

      Currently there are no requirements for patients however as per the regulatory update on 22nd October 2020, the Company is pleased to confirm that following its third pre-submission meeting with FDA, there was preliminary agreement on the design and scope of a small supplementary study, known as "FM71" subject to the issue of the final meeting minutes. Detailed planning for the study has now commenced and Futura is targeting Q1 2021 patient enrolment depending on completion of the final study protocol for FM71.

      Patients interested in participating will be able to find details in due course on ClinicalTrials.gov.

    • What are your plans for MED2005 post Phase 3?

      Futura is pursuing the medical device regulatory pathway for its proprietary transdermal formulation MED3000 in the US and Europe.

    • What were the results of the European Phase 3 study, FM57?

      Results of the FM57 study can be found here

    • When do you expect Thornton & Ross to obtain regulatory approval within the UK?

      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. 

      As mentioned in the Interim Results for the Six Months ended 30 June 2020 (September 2020 RNS) post period events:

      • Additional laboratory work required by the UK Medicines and Healthcare products Regulatory Agency ("MHRA") to support the UK submission made by partner Thornton & Ross (a subsidiary of STADA AG) has been completed.
      • In conjunction with its commercial partner, Futura is seeking a scientific advisory meeting with the MHRA before year end to review data and confirm the exact pathway for approval.
    • What formulation of DermaSys® is used for the TPR100 product? How does this differ from MED3000?

      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.

    • What is the IP position of this specific formulation?

      TPR100's current patent protection runs until February 2028 in the USA and Europe.

    • Who are CBDerma Technology Ltd?

      CBDerma Techology 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.

       

    • What are the potential market sizes for cannabidiol either as a cosmetic or a pharmaceutical?

      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.

    • Why is DermaSys® an ideal product formulation for cannabidiol?

      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.

    • What formulation of DermaSys® is used for the CBD100 product? How does this differ from MED3000?

      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.

      At this stage the formulation for CBD100 is still under development. Nevertheless, CBD100 does not require a combination of volatile solvent components to stimulate nerve sensors.  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.

    • What is the IP position of this specific formulation?

      A patent application was filed in the UK in August 2020.

    • When will you hear back about the CBD100 patent application?

      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.

    • What will be the next steps with CBD100?

      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.

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