07 November 2005
Futura Medical plc Announces preliminary results from MED2003/4/5 pharmacokinetic 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 first 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).
Sixteen Subjects have completed an escalating dose study in which they received six different gels applied directly to the penis over a three week period thereby allowing a suitable period of time between each different gel application. All six gels contained the compound glyceryl trinitrate (GTN) within three gel formulations, MED2003, MED2004 and MED2005, which have been developed to deliver GTN into the penile tissues at different rates.
An excellent safety profile was achieved with a dose-related response in terms of incidence and severity of adverse events based on the strength and rate of release of GTN from the gels. The adverse events reported were predominantly mild headaches which were pharmacologically predictable, resolved spontaneously and did not require treatment. No serious adverse events were recorded and no falls in blood pressure seen. Levels of GTN within the Subjects’ blood plasma indicate a highly favourable pharmacokinetic profile characterised by rapid absorption and elimination of the compound. In addition the absorption profile is consistent with the intended use of the product in the treatment of erectile dysfunction, suggesting a rapid onset of action, within a few minutes of product application, and no prolonged side effects.
James Barder , Chief Executive of Futura, said: “ We are greatly encouraged by these preliminary results of this pharmacokinetic study. We firmly believe we have identified the correct dose and formulation to deliver a GTN level that is well tolerated and safe. A second placebo-controlled study investigating the pharmacodynamic events of these new formulations has recently completed and we expect to able to release the results of this study towards the end of November.”