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.
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