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Futura Confirms Receipt of US FDA Minutes
Futura Confirms Receipt of US FDA Minutes.
About this update from Futura Medical Plc
[{"type":"text","content":"\n \n \n RNS Number : 8130I\n Futura Medical PLC\n 06 April 2020\n \n \n \n \n 6 April 2020\n \n \n \n \n \n Futura Confirms Receipt of US FDA Minutes\n \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® technology and currently focused on sexual health and pain, is pleased to announce that it has received official minutes from the US Food and Drug Administration (FDA) following its pre-submission meeting on 24 February 2020.\n \n \n \n \n \n The Company presented existing clinical evidence from its Phase 3 Study (FM57) and the case for filing for FDA clearance for its lead product, MED3000, a topical treatment for Erectile Dysfunction (ED), as a medical device with a De Novo Classification. This follows top line results from the FM57 study announced in December 2019, that demonstrated that MED3000 has the potential to be a highly effective, clinically proven, topical treatment for ED, with a fast onset of action and excellent safety profile.\n \n \n \n \n \n The minutes confirm the Company's expectations as disclosed in the Full Year Results 2019, announced on 1 April 2020, that the US FDA has agreed to a De Novo medical device application subject to Futura pursuing another pre-submission meeting to further discuss clinical sufficiency and/or post-marketing requirements once the clinical study report (\"CSR\") for FM57 is available. Management expects this second meeting to take place in the coming months. If successful, this could lead to a US submission filing in Q3 2020 for FDA review for pre-marketing clearance. \n \n \n \n \n \n \n James\n \n Barder, Chief Executive of Futura Medical, commented: \"We are very pleased to have received official confirmation of what will be required to progress MED3000 towards a potential approval as a medical device as a clinically proven ED therapy. Futura remains in consultation with the FDA regarding overall data requirements as we move towards targeted regulatory submissions for MED3000 in both the US and EU in the next six months\n .\n \n \n \n \n \n \"The Company also announced in February 2020, following positive interactions with an EU Notified Body1, that it had commenced formal proceed...