Futura’s unique technology DermaSys® enables targeted and rapid delivery of clinically proven effective pharmaceutical treatments through the skin to the required site of action.
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.
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.
MED3000, our lead product, is a topical gel which utilises our proprietary technology DermaSys®, developed specifically for the treatment of erectile dysfunction (“ED”). MED3000 has the potential to be a highly differentiated product by addressing significant unmet needs in the ED market.
MED3000 has the potential to be 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 and will target mid 2020 for both regulatory the submissions in the US and EU.
Futura will submit its technical file for review by 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 in mid-2020.
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, 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.
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 of GTN.
The recruitment for the European Phase III study (FM57) is now closed
For further details on the trial, please visit ClinicalTrials.gov.
Unfortunately, under the current regulations, Futura Medical are not able to provide samples.
For further details on the trial, please visit ClinicalTrials.gov.
MED3000 was subject to a recent filing application made in December 2019, if successful this could provide patent protection until 2040.
MED2005's current patent protection runs until August 2028 in the USA and August 2025 in Europe. In addition EU rules grant a 10 year protection. Futura would benefit from a period of 8 years’ exclusivity during which data generated by Futura cannot be used for an MAA to support their application. In addition no generic of the product may be marketed for 10 years after the first approval.
In August 2018 Futura filed a Patent Co-operation Treaty patent application which, if successful, could extend patent protection in many countries to 2038. The PCT filing will be moving into the National filing phase in Q1 2020 in line with standard processes. This phase sets out specific, nominated countries under the Patent Co-operation Treaty which, if successful, will provide patent coverage until 2037.
Futura now plans to pursue 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 lab work specifically around the permeation characteristics of TPR100 to be conducted. This work is progressing, and we expect Thornton & Ross to respond by the end of February 2020 within the timelines agreed with the MHRA.
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.
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.
CB Derma Techology is a shell company that has been established with backers that have experience in plant derived products. They see this as an interesting new opportunity and are happy to share the development costs at this stage.
The cosmetic market is already significant with the UK, we understand, over £300 million. As a topically applied Pharmaceutical the potential is huge, with currently very little credible scientific research conducted on topical formulations.
DermaSys® provides rapid and targeted local delivery of active pharmaceutical ingredients at therapeutic levels 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.
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 of the local distributor.
We cannot comment on specific countries but in MENA & EU