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Futura Medical provides EU & US regulatory update
Futura Medical provides EU & US regulatory update.
About this update from Futura Medical Plc
[{"type":"text","content":"\n \n \n RNS Number : 8724S\n Futura Medical PLC\n 14 July 2020\n \n \n \n \n \n \n \n 14 July 2020\n \n \n \n \n \n Futura submits MED3000 under the EU Medical Device Regulation and provides update on US regulatory proceedings \n \n \n \n \n Futura Medical plc (AIM: FUM) (\"Futura\" or the \"Company\"), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain, is pleased to announce that it has now submitted the product dossier for its treatment of erectile dysfunction (\"ED\") known as MED3000 under the European Medical Device Regulation for marketing approval.\n \n In February 2020, Futura commenced formal proceedings for MED3000 to be approved as a medical device and a clinically proven treatment for Erectile Dysfunction (ED) in Europe by an EU Notified Body1. These proceedings have now allowed the Company to submit the MED3000 product dossier for review, including the Clinical Study Report (CSR) for FM57 and technical specifications of the Company's Quality Management System. The Company expects to be able to provide a further update on the progress of MED3000 EU regulatory approval at the time of its interim results in September but continues to target a 2021 approval date.\n \n The Company has also now had a second pre-submission meeting with the US Food and Drug Administration (FDA), as a result of which the Board believes a pathway to a marketing approval for MED3000 in the USA has been established, and importantly, without the need for a doctor's prescription. None of the market leading treatments for ED, such as Viagra and Cialis, are currently approved in the USA without the need of a doctor's prescription and the Company has seen a high level of interest from potential commercial partners for a clinical proven treatment for ED which is available without the need of a doctor's prescription, known as Over the Counter (\"OTC\").\n \n The FDA have indicated a requirement for certain additional clinical efficacy data beyond the Company's three months' home use study conducted in 2019 in 1,000 patients suffering from mild, moderate and severe ED (\"FM57\"). This additional data will require a further small clinical trial where pati...