Business
Update on positive EU regulatory discussions
Update on positive EU regulatory discussions.
About this update from Futura Medical Plc
[{"type":"text","content":"\n \nRNS Number : 8373C Futura Medical PLC 13 February 2020 \n\n \n \n13 February 2020\n \nFutura provides update on positive EU regulatory discussions and further ongoing analysis of FM57\n \nFutura 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, provides an update on positive initial discussions with EU regulators. This follows an extensive internal evaluation of the clinical data from the Phase 3 study (\"FM57\") announced on 10 December 2019. Futura confirms that it is pursuing the medical device regulatory pathway for its erectile dysfunction (ED) product, which utilised the DermaSys® technology and was used as the control formulation in FM57 and is now known as MED3000.\n \nAs previously announced, top line results from FM57 showed that MED3000 has the potential to be a highly effective, clinically proven, topical treatment for erectile dysfunction. MED3000 has a unique evaporative mode of action which the Board believes stimulates nerve endings to cause an erection. As such, it does not require the inclusion of glyceryl trinitrate.\n \nRegulatory Update\nOn 20 December 2019, the Company announced that it was planning consultations with external regulators to provide clarity on potential timing and further requirements for approval in both the EU and USA.\n \nFollowing recent positive interactions with an EU Notified Body (Notified Bodies are the regulatory authorities that oversees the approval of medical devices within the EU for all EU countries including the UK), Futura yesterday commenced formal proceedings for MED3000, the Company's gel formulation, as a clinically proven treatment for ED to be approved as a medical device. These proceedings will allow the Company to submit its technical file for review by the said Notified Body, including the full clinical study report for FM57 and the Company's Quality Management System in mid 2020.\n \nFeedback from these initial discussions also indicates that MED3000 represents a wider overall commercial opportunity, due to its broader applicability, providing a clinically proven and safe treatment to ED patients as a standa...