15 November 2004
Futura Medical announces preliminary results from FLD500 study
Futura Medical plc ("Futura"), the AIM-quoted pharmaceutical drug and medical device group that develops innovative products for the sexual healthcare market, announces the completion of the clinical trial in healthy female volunteers ("Subjects") at the internationally renowned Porterbrook Clinic in Sheffield, UK.
Ten Subjects completed a single-blind, placebo-controlled, phase I trial. Four Subjects received placebo and three different lower-strength doses of Glyceryl Trinitrate ("GTN"), whereas the remaining six Subjects received placebo and three different higher-strength doses of GTN.
Application of the compound to the Subjects was found to be safe and well tolerated at the lower-strength doses, with no adverse events experienced during the twelve exposures. Subjects receiving the higher-strength doses reported dose-related adverse events, predominately headaches, ranging from mild to severe in intensity. No clinically significant changes in blood pressure, haematology or biochemistry profiles were seen in any Subjects at any of the dose levels.
Efficacy was assessed by monitoring vaginal microcirculation using photoplethysmography. Positive responses were more frequent in the group receiving the lower-strength doses, where the compound was also considered safe and well tolerated. The pattern of changes observed mimic the blood flow changes seen in women during clitoral stimulation and sexual arousal. These preliminary results will allow Futura to select the preferred doses from the lower-strength group for pivotal studies.
James Barder , Chief Executive of Futura, said: " We are encouraged by these preliminary results of this pilot study for FLD500. We will be discussing them with our potential distribution partner in the near future before moving on to conducting a pivotal study in 2005."