Futura Medical Regulatory News (FUM)

Futura Medical plc

("Futura" or the "Company")

Update on Pain Relief Clinical Programme

Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce that it will shortly be making a submission to UK regulators for approval to begin a clinical study to assess the efficacy and safety of its three topical pain relief products, which have already shown rapid skin permeation in earlier studies.

The products - whose active ingredients include diclofenac, ibuprofen and methyl salicylate - use the Company's novel topical delivery technology DermaSys®. It is expected that the clinical phase will commence in Q1 2015 with results available during the summer 2015.

This study will compare the three products - TPR100, TIB200 and SPR300 - against placebo and/or against marketed products in a model of inflammatory pain in which the skin of healthy volunteers will be carefully exposed to a controlled amount of ultra-violet light to increase the sensitivity of the skin to pain stimuli. This approach removes some of the subjectivity and variability associated with studying pain in patients being treated for painful conditions.

TPR100, Futura's novel diclofenac gel, will be compared against a market-leading diclofenac gel, against orally delivered diclofenac and against a placebo of TPR100's gel. TIB200, Futura's novel ibuprofen gel, will be compared against a market-leading ibuprofen-containing gel, against orally delivered ibuprofen and against a placebo of TIB200's gel. 

The endpoints for TPR100 and TIB200 include equivalence with the marketed topical products against which they are being compared and also how they compare with oral versions of the marketed products. Systemic absorption of the active ingredients will be studied to identify any differences in the absorption profiles of the test products and these will be correlated with the side effect profiles. In addition to equivalence, the study will identify any potential superiority of TPR100 and TIB200 compared with the marketed products, for example, in depth, speed of onset or duration of pain relief.

SPR300 will be compared only against a placebo of the gel used in SPR300 as, following consultation with UK regulators, there is no appropriate marketed methyl salicylate product that can be used as an active comparator. The endpoints of the trial for all three products are designed for regulatory approval requirements as well as to identify any potentially strong marketing claims.

The trial is of a randomised, double blind, crossover design in a total of 60 subjects, divided into three groups of 20 who will receive one of TPR100, TIB200 or SPR300 and controls.

James Barder, Futura's Chief Executive, said: "We have already demonstrated rapid skin permeation with our topical pain relief portfolio in vitro and this study is designed to demonstrate efficacy, both against placebo and against currently marketed products. The endpoints of the study have been chosen to highlight potentially strong marketing and clinical efficacy claims, which would reinforce the products' commercial positioning. We continue in discussions with potential licensing partners in connection with our pain relief portfolio although our primary focus at the moment is the successful completion of this important study and we look forward to the start of this clinical evaluation next year."

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About 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.com