Futura files for Further Pre-Submission meeting with the FDA following receipt of its Phase 3 clinical study report
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 now filed for a further pre-submission meeting with the US FDA following receipt of the complete and signed clinical study report (CSR) for its Phase 3 Study (FM57). This follows initial presentation of existing clinical evidence from the FM57 study at an FDA pre-submission meeting on 24th February 2020.
FM57 reported top line results in December 2019. It was a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study for the Company’s lead product, MED3000, a topical treatment for Erectile Dysfunction (ED). It 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.
As disclosed on 6 April 2020, the US FDA has agreed to a De Novo medical device application for MED3000 subject to Futura pursuing another pre-submission meeting to further discuss clinical sufficiency and/or post-marketing requirements, with reference to the full FM57 CSR and other supporting information. Futura has now filed for the pre-submission meeting and expects this second meeting to take place in the coming months. If the outcome of the meeting is positive, this could lead to a US submission filing in Q3 2020 for FDA review for pre-marketing clearance.
James Barder, Chief Executive of Futura Medical, commented: “Following extensive review of the clinical data, we are pleased to have received the completed and signed CSR 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/or post-marketing requirements for MED3000. As a breakthrough treatment for erectile dysfunction (ED), 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 USA.”
- Futura Medical plc
- Futura Medical plc