21 November 2005
Preliminary results from MED2003/5 pharmacodynamic study
Futura Medical plc (AIM: FUM), the pharmaceutical drug and medical device group that develops innovative products for the sexual healthcare market, announces the completion of the second of two clinical trials in healthy male volunteers (Subjects) to evaluate three novel formulations of its topical gel for the treatment of erectile dysfunction (ED).
Fifteen healthy males have completed a placebo controlled, double-blind, randomised study. Each Subject received four different doses of glyceryl trinitrate (GTN) in gels that were applied directly to the penis. The gels have been designed to deliver GTN into the penile tissues more efficiently than previous formulations.
As with the initial pharmacokinetic study, the results of which were announced on 7 November 2005, an excellent safety profile was observed. Dose-dependent side effects, which were predominantly mild headaches resolving without the need for treatment, were seen in fewer than 10% of all dosing events. No serious adverse events were recorded and no falls in blood pressure occurred in any of the subjects at any GTN dose. As with the pharmacokinetic study, GTN doses up to 0.25mg were found to be safe and well tolerated.
The effects of GTN on penile blood flow were assessed during this study using Doppler ultrasound technology. Despite the lack of sexual stimulation, many Subjects displayed penile blood flow changes following GTN dosing which were consistent with those seen during sexual arousal. In particular, the rate of blood flow into the penis, as recorded by the Peak Systolic Velocity (PSV), demonstrated increases in most of the Subjects on application of drug relative to baseline and compared with placebo. For example, with the preferred formulation approximately 70% of Subjects showed a greater increase in PSV relative to baseline compared with placebo, an outcome that was statistically significant.
Dr Paul Sidhu, a consultant radiologist at King’s College Hospital, London, and one of the leading experts in penile Doppler ultrasound, confirmed that the changes recorded by Doppler ultrasound after exposure to the gels were consistent with those seen during sexual arousal. He also felt this was an encouraging indicator of the potential efficacy of the gels for the treatment of erectile dysfunction which will need to be verified by the Phase III clinical programme.
James Barder, Chief Executive of Futura, said: “These results are excellent. When considered with the recent pharmacokinetic results we believe that they provide an excellent platform for our Phase III programme. Futura is firmly on track to developing the world’s first ‘non-prescription’ treatment for erectile dysfunction. ”