PET500 will utilise
our skin delivery technology
PET500 is a topical spray developed for men who want greater levels of sexual control. It is designed to meet the requirements of men who suffer from occasional early ejaculation as well as those suffering from clinically diagnosed premature ejaculation. Applied directly to the penis, PET500 enables men to prolong their sexual experience and sexual enjoyment, increasing satisfaction for them and their partner.
PET500 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 eight 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.
In February 2011, we signed an exclusive worldwide agreement with Ansell Ltd for the distribution rights to our product for premature ejaculation PET500. Ansell has already developed the strategy for the launch of the product, which is expected to take place as soon as practicable. Under the terms of the agreement with Ansell, Futura will receive a significant royalty rate on sales and a modest upfront payment. The branding of the product will be developed by Ansell, which will also be responsible for the product's manufacture and for funding of all regulatory work. Futura will work closely with Ansell on the successful completion of any clinical work in territories where regulators require additional data.