The AIM-listed firm said this trial will be a dose ranging, multicentre, randomised, double-blind, placebo-controlled, home use, parallel group clinical trial of topically applied glyceryl trinitrate (GNT).
The healthcare company said the study will recruit approximately 1,000 patients with mild, moderate and severe ED and compare the efficacy of 0.2%, 0.4% and 0.6% GTN doses of MED2002 against that of the placebo.
The trial will be conducted throughout Eastern Europe with a three-month study period for each patient.
Futura said it is confident that the positive pharmacokinetic data published this month supports the decision to conduct Phase III studies at higher doses than previously studied, with 0.6% GTN the maximum dose that would likely be considered suitable for the 505(b)(2) regulatory pathway in the USA.
Depending on the speed of regulatory approval and patient recruitment proceeding, Futura expects the first patient to be dosed by the end of September 2018, and headline efficacy results to be announced by the end of December 2019.
James Barder, chief executive of Futura Medical, said: “The potential for MED2002 as a safe, rapid and effective treatment for erectile dysfunction is huge. We are pleased to report that discussions regarding commercialisation are progressing and we look forward to providing shareholders with a further update at the appropriate time.”