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.
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.
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 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.
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.
Futura now plans to pursue the medical device regulatory pathway for MED3000. Futura has commenced formal proceedings for MED3000 as a clinically proven treatment for ED to be approved as a medical device for the treatment of ED. Futura is expecting to submit the dossier to EU regulators by the end of July 2020 with the U.S. FDA providing optimism for submission for a medical De Novo device approval filing by end of Q3 2020.
Futura will submit its technical file for review by an EU Notified Body (Notified Bodies are the regulatory authorities that oversees the approval of medical devices within the EU for all EU countries including the UK), including the full clinical study report for FM57 and the Company’s Quality Management System.
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. The regulatory pathway for a medical device is expected to be faster. An EU Notified Body has confirmed that MED3000 is a medical device and the US FDA has confirmed that the classification for the filing of MED3000 is a De Novo medical device.
These regulatory positions are the consensus from a number of regulatory experts consulted by Futura, nevertheless the Company is meeting with respective regulators ahead of regulatory filings.
Unfortunately, under the current regulations, Futura Medical are not able to provide samples.
MED3000 discussions are progressing well with regulators with an EU filing expected by the end of July 2020 and with positive dialogue with the US FDA providing optimism for a submission for a medical de novo device approval filing by the end of Q3 2020.
The recruitment for the European Phase 3 study (FM57) is now closed.
MED3000 achieved all co-primary clinical endpoints against baseline (before treatment). We are now pursuing regulatory filings as a medical device in the EU and US.
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.
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.
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.
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.
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.
Futura is pursuing the medical device regulatory pathway for its proprietary transdermal formulation MED3000 in the US and Europe.
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. Ongoing laboratory work continues with formulation dosing adjustment and in vitro studies to enable TPR100 to meet the strict criteria established by the MHRA (to avoid the need to conduct a Phase 3 pain relief efficacy study) delaying the response to the MHRA by at least six months.
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.
TPR100's current patent protection runs until February 2028 in the USA and Europe.
The cosmetic market is already significant with the UK, we understand, over £300 million. As a topically applied pharmaceutical the potential is very significant, with currently very little credible scientific research conducted on topical formulations.
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.
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 and is not yet fully optimised. Nevertheless CBD100 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 being formulated with this objective in mind.
At this stage the formulation for CBD100 is still under development and is not yet fully optimised. A patent application will only be filed once the formulation is optimised. Optimisation work is progressing, and the first stage of this will be complete by end of July 2020 before the next stage of early proof of concept studies are being considered.
As previously commented following the hand back of rights by both Reckitt Benckiser and C&D without a strong brand carrier CSD500 no longer remains a priority for Futura. Futura continues to assist its other licensees in their efforts to launch CSD500 but Futura has no plans for future development work for CSD500.
This is a choice for the local distributor.
We cannot comment on specific countries but in MENA & EU