Clinical Study of Pain Relief Portfolio Commences
18 March 2015
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce that the screening of subjects is under way in an important clinical study of its portfolio of three topical pain relief products, all of which benefit from the rapid skin permeation offered by the Company's transdermal delivery system, DermaSys®.
The well characterised active ingredients in the three products comprise diclofenac, ibuprofen and methyl salicylate, codenamed TPR100, TIB200 and SPR300 respectively.
The three products are being tested in a controlled induced pain model 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.
The study 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.
Two different strengths of 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, onset of action, duration and/or degree 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 to meet regulatory requirements as well as to help identify any potentially strong marketing claims.
The results from the study are expected by the end of July.
James Barder, Futura's Chief Executive, commented: "We are delighted that this potentially pivotal clinical study of the three products in our topical pain relief portfolio is now under way. We look forward to receiving the read-out from the study by around the end of July this year.
"The skin permeation rates we have achieved in earlier tests using our DermaSys® delivery system suggest that our pain relief portfolio is potentially highly competitive, for example in speed of onset of action of pain relief."
For further information please contact:
Aubrey Powell / Liz Yong
Tel: +44 (0) 20 7496 3000
For media enquiries please contact:
Mark Court / Sophie Wills /
Stephanie Watson / Tilly Abraham
Tel: +44 (0) 20 7466 5000
Notes to editors:
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.