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Final Dosing of Last Patient in MED2005 Ph3 study
Final Dosing of Last Patient in MED2005 Ph3 study.
About this update from Futura Medical Plc
[{"type":"text","content":"\n \nRNS Number : 4430Q Futura Medical PLC 21 October 2019 \n\nFinal Dosing of Last Patient in MED2005 Phase 3 study\nFirst European Phase 3 study \"FM57\" on track to deliver headline data by the end of 2019\nPatient recruitment complete for open label extension study\n \n21 October 2019\n \nFutura Medical plc (AIM: FUM) (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, is pleased to announce that all patients have now completed dosing in the first European Phase 3 study, \"FM57\", of MED2005. Futura remains on track to deliver headline data by the end of 2019. In addition, patient recruitment has recently been completed for the required 12 month open-label extension study (\"OLE\").\n \nFinal FM57 dosing complete\n \nFM57 is a pivotal 1,000 patient study that includes approximately 60 centres across Central and Eastern Europe. This Phase 3 study is a dose ranging, randomised, double blind, placebo controlled, home use, parallel group clinical trial and evaluates the efficacy and safety of 0.2%, 0.4% and 0.6% GTN doses of MED2005 in mild, moderate and severe erectile dysfunction (\"ED\") patients.\n \nOpen Label Extension study\n \nA 12-month open-label extension study to assess long-term safety and tolerability of a drug is a standard regulatory requirement for drugs intended for long-term treatment of non-life-threatening conditions, such as ED. In line with advice received from regulatory authorities, Futura has designed an OLE in which subjects recruited from primarily high patient volume countries are invited to enter into the OLE on the 0.6% dose a few days after completing the double-blind phase and follow up visit of FM57. In OLE studies, generally 300 to 600 patients are evaluated for 6 months and at least 100 of those patients for 12 months; defined by the International Conference on Harmonisation (ICH) guideline E1. Therefore, to meet this requirement, Futura are pleased to announce that 450 subjects from the double-blind phase of FM57 have agreed to enter the OLE study. As previously reported on 11 September 2019 interest in patients electing to enter the OLE remained high having completed the double-blind pha...