Futura Medical Regulatory News (FUM)

9 Dec 2008 07:00



Futura Medical plc

("Futura" or "the Group" or "the Company")

Positive Phase I results for PET500 

Futura Medical plc (AIM: FUM), the pharmaceutical group that develops innovative products for consumer healthcare, is pleased to announce positive results from its Phase I study of PET500, the Company's innovative treatment for premature ejaculation. PET500, which has been developed in gel and spray formulations, combines Futura's highly effective DermaSys® delivery system with a mild anaesthetic.

In a 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 prevent premature ejaculation. Penile sensitivity was measured in a clinical setting by the use of Von Frey microfilaments. No adverse events were recorded in the study.

PET500's formulation is designed to delay ejaculation for a period of approximately 8 minutes, after which time the effect of the mild anaesthetic dissipates. The Phase I study met all endpoints, which 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.

Futura has received interest in PET500 from a number of potential partners and will update shareholders on progress with the product's development and commercialisation in due course.

In response to the technical challenge of formulating PET500, Futura has expanded its DermaSys® delivery technology platform by designing a unique non-aqueous carrier, DermaSys® AquaFree. This new system, which incorporates the benefits of our existing DermaSys® technology, provides the opportunity for hydrolytically unstable drugs to be developed into commercially attractive topical products. 

James Barder, Futura's Chief Executive, said: "The positive results from this Phase I study give us confidence in conducting further studies of PET500 as an over-the-counter treatment for premature ejaculation, a market that presents a considerable unmet clinical need. In addition, PET500 uses a new version of our DermaSys® delivery system called DermaSys® AquaFree, which expands the range of applications for our proprietary drug delivery technology."

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Notes to Editors

Futura Medical plc

Futura Medical is a pharmaceutical group that develops innovative products for consumer healthcare. The Company is developing a portfolio of products and its strategy is to license their manufacture and distribution to major pharmaceutical and healthcare groups.

Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange.

www.futuramedical.co.uk