Business
Recruitment Closes in MED2002 Study
Recruitment Closes in MED2002 Study.
About this update from Futura Medical Plc
[{"type":"text","content":"\n \nRNS Number : 1417X Futura Medical PLC 04 May 2016 \n\n\n\n\n\nFor immediate release\n\n\n4 May 2016\n\n\n\n\n \n \n \n \nFutura Medical plc\n(\"Futura\" or \"the Company\")\n \nRecruitment Closes in MED2002 Pivotal Study\n \nFutura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce that it has closed recruitment of patients into its pivotal clinical study of MED2002, the Company's novel, topical gel for the treatment of erectile dysfunction (ED).\n \nPatient recruitment has taken place at four sites in the UK and Poland. Remaining appointments are being completed this week to give a total of around 360 patients consented into the study. This number is considered sufficient for the completion of the study, which requires the treatment of 192 eligible patients.\n \n110 patients have already completed the study and the remaining 82 are expected to complete during the summer. Each eligible patient typically takes four months from the point of consent to completing the study, meaning that headline results are now expected in Q3 2016.\n \nNo serious adverse events have been recorded to date among the patients who have participated in the study, which is of a randomised, placebo-controlled, double blind, home use, crossover design.\n \nThis pivotal study began in June 2015 and its primary endpoint is the MED2002's efficacy in male subjects self-diagnosed with ED using the erectile function domain of the International Index of Erectile Function (IIEF). The IIEF is a well validated measure of erectile function and was used for the approval of PDE5 inhibitors, such as Viagra®. Secondary endpoints in the trial include the speed of onset, which the Company believes is an important claim for the product.\n \nMED2002 is expected to be a prescription-only product. It has patent protection until 2025 in Europe and until 2028 in the USA.\n \nJames Barder, Futura's Chief Executive, commented: \"We are very pleased to have closed recruitment into this pivotal study of MED2002 in erectile dysfunction, a condition with significant unmet medical need. We look forward to receiving the headline results of the study in Q3 2016. Commercialisation plans are already being prepared in anticipation of a succes...