Futura Medical PLC (LON:FUM) has been asked to attend a second meeting with the US Food & Drug Administration (FDA) to assess its topical erectile dysfunction treatment MED3000 as a medical device rather than a drug.
The company met with the FDA for a pre-submission on 24 February and has now received the official minutes back.
These confirm that the US regulator has agreed to a De Novo medical device application for MED3000 subject to another pre-submission meeting to discuss clinical sufficiency and/or post-marketing requirements once the clinical study report or CSR for the FM57 study is available.
Futura published topline results from the FM57 study for MED3000 in December.
It said it expects the second meeting with the FDA to take place in the coming months.
If successful, this could lead to a US submission filing in the third quarter of this year for FDA review for pre-marketing clearance, the group added in a statement.
James Barder, Futura's chief executive 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.”
In Europe, formal proceeding are now underway for approval, Barder added, with the CSR expected to be submitted to the appropriate body by July," he added.