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).
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.
Unfortunately, under the current regulations, Futura Medical are not able to provide samples.
The recruitment for the clinical study has closed and the study completed. For further details on the clinical trial, please visit ClinicalTrials.gov.
After the Phase 3 FM57 study indicated the value and efficacy of MED3000 (a formulation developed specifically for the treatment of ED) a new patent application was filed in December 2019 which has the potential, if successful, to extend protection of MED3000 until 2040. 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.
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 for MED2005 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 is pursuing the medical device regulatory pathway for its proprietary transdermal formulation MED3000 in the US and Europe.
Results of the FM57 study can be found here