Futura files for second FDA meeting over erection gel

Futura Medical has filed for a further pre-submission meeting with the US Food and Drug Administration (FDA), it announced on Monday, following receipt of the complete and signed clinical study report for its phase 3 Study, ‘FM57’.

The AIM-traded firm said the filing followed the initial presentation of existing clinical evidence from the FM57 study at an FDA pre-submission meeting on 24 February.

It noted that FM57 reported top line results in December, describing it as a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study for its lead product, ‘MED3000’ - a topical treatment for erectile dysfunction (ED).

The study reportedly demonstrated that MED3000 had the potential to be a highly effective, clinically proven topical treatment for erectile dysfunction, with a fast onset of action and excellent safety profile.

As it disclosed on 6 April, the US FDA had agreed to a ‘De Novo’ medical device application for MED3000, subject to Futura pursuing another pre-submission meeting to further discuss clinical sufficiency and post-marketing requirements, with reference to the full FM57 clinical study report and other supporting information.

Futura said it had now filed for the pre-submission meeting, and expected that second meeting to take place in the coming months.

If the outcome of the meeting is positive, it could lead to a US submission filing in the third quarter of 2020, for FDA review for pre-marketing clearance.

“Following extensive review of the clinical data, we are pleased to have received the completed and signed clinical study report for FM57, and have filed the necessary data in order for the company to have the next pre-submission meeting to further discuss clinical sufficiency and post-marketing requirements for MED3000,” said chief executive officer James Barder.

“As a breakthrough treatment for erectile dysfunction, we are confident that we will receive MED3000 approval as a medical device, and we continue to target the next six months for regulatory submissions in both Europe and the US.”

At 1557 BST, shares in Futura Medical were up 11.22% at 11.4p.