Futura Medical Announces First Patient visit in MED3000 Confirmatory Study required for US approval

Futura 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, today announces that the first patient visit has occurred in the confirmatory clinical study, FM71, for MED3000 that will be supporting the US regulatory submission for the product.

MED3000 is a breakthrough, fast acting topical gel formulation for the treatment of erectile dysfunction (“ED”) and is CE marked in Europe and the UK as a clinically proven topical treatment for adult men with erectile dysfunction.

The start of FM71 is in line with planning and both the FM71 and non-clinical Human Factors studies are now progressing in parallel targeting patient completion by the end of Q2 2022 in order for submission of MED3000 for US regulatory approval as a DeNovo medical device for ED treatment, with OTC classification by end Q3 2022. US marketing authorisation therefore remains on track for approval of MED3000 in Q1 2023.

Read more…

By Optimum

For more information about Optimum Strategic Communications, please get in touch

We'd love to hear from you...