Pain Relief Portfolio: Study Update
18 May 2015
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce a progress update on its clinical study of its portfolio of three topical pain relief products. Two out of the three cohorts have been completed. Dosing of the final cohort of the methyl salicylate product, SPR300 is expected to commence shortly.
Guidance initially suggested that results are to be expected at the end of July, but due to the pace of progress across this study, headline results are now expected in mid-July.
As detailed in the announcement on 18 March 2015, the three products benefit from the rapid skin permeation offered by DermaSys®, the Company's transdermal delivery system, and each contains one of the well-characterised active ingredients diclofenac, ibuprofen and methyl salicylate.
The study is of a randomised, double blind, crossover design in a total of 60 subjects, divided into three cohorts of 20 run sequentially.
The TIB200 cohort, in which TIB200 is being compared with currently marketed ibuprofen products and the TPR100 cohort, in which TPR100 is being compared with currently marketed diclofenac products, have both completed although the results remain blinded until completion of the entire study. The SPR300 cohort, in which SPR300 is being compared with placebo, is on track to complete recruitment shortly.
The three products are being tested in a controlled induced pain model in which the skin of healthy volunteers is being 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.
James Barder, Futura's Chief Executive, commented: "We are delighted by the progress being made in this clinical study of the three products in our topical pain relief portfolio. 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. Our earlier work suggests that our pain relief portfolio is highly competitive, for example, in speed of onset of action of pain relief. We now look forward to receiving the headline data from the study in mid-July this year."
For further information please contact:
Aubrey Powell / Liz Yong / Thomas Smale
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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.