PET500 is designed to meet the requirements of men who suffer from occasional early ejaculation as well as men suffering from clinically diagnosed premature ejaculation. PET500 gives men greater control over their sexual performance so that they can prolong their sexual experience and sexual enjoyment, increasing sexual satisfaction for them and their partner.
PET500, which has been developed as a spray, combines Futura's highly effective DermaSys® delivery system with a mild anaesthetic. PET500's formulation is designed to provide extra control for a period of approximately 8 minutes, after which time the effect of the mild anaesthetic dissipates.
In December 2008, Futura announced positive results from a Phase I study which met all endpoints. The endpoints were devised following consultation with a number of leading medical experts in the field of premature ejaculation and on the basis of qualitative market research in patients. In this Phase I study of 20 healthy volunteers, PET500 was shown to give a rapid and controlled reduction in penile sensitivity, thereby having the potential to delay ejaculation. Penile sensitivity was measured in a clinical setting by the use of Von Frey microfilaments. No adverse events with the active product were recorded in the study.
The marketing positioning of the product will depend upon local regulatory requirements including the status of existing regulatory approvals for the active ingredients. A home use clinical study will be required for some markets including those in the EU. In considering how to market the product and subject to local regulatory requirements, we believe that 'enhanced sexual control' is a more attractive marketing positioning for the product.
The PET500 formulation has been successfully modified to comply with the current USA Food and Drug Administration monograph for male genital desensitisers. The product can therefore be marketed in the USA without any further regulatory approval or clinical data, a position confirmed by independent regulatory consultants based in the USA.
PET500 is not currently partnered though we are in commercial discussions with several parties.
PET500 will utilise our skin delivery technology
