First European Phase 3 study “FM57” on track to deliver headline data by the end of 2019
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 currently focused on sexual health and pain, is pleased to announce the completion of patient recruitment for the first European Phase 3 study, “FM57”, of MED2005. Futura remains on track to deliver headline data by the end of 2019.
FM57 has completed recruitment of over 1,000 patients in the study for the treatment of mild, moderate and severe erectile dysfunction (“ED”). The study includes approximately 60 centres across Central and Eastern Europe and will compare the efficacy of 0.2%, 0.4% and 0.6% GTN doses of MED2005 against that of placebo with an initial three-month study period for each patient. FM57’s protocol incorporates feedback received from world leading key opinion leaders (“KOLs”) in ED, the US and EU regulatory agencies, as well as potential commercial partners, to increase the chances of regulatory approval as well as optimising the commercial value.