Pain Relief Portfolio
14 July 2015
Headline Results from Pain Relief Portfolio Study
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce headline results from its clinical study of the Company's portfolio of three topical pain relief products. The headline clinical data from the two non-steroidal anti-inflammatory (NSAID) products is very encouraging, with both products achieving all of their primary clinical endpoints. The data provides a clear pathway for the products' further development and reinforces the Company's expectation of their commercial potential.
The final study report is expected in September though preliminary analysis suggests there may be additional data to support strong marketing claims for the two NSAID products. Futura believes that certain trends observed may be indicative of the improved permeation of active compound through the dermis achieved by the Company's DermaSys® topical delivery system.
The clinical study of a total of 60 subjects compared each of the three products against a placebo. It also compared them against currently marketed products to show equivalence, which is a strategy frequently used in the consumer healthcare industry as it gives the potential for strong marketing claims whilst reducing the clinical requirements for regulatory approval.
The clinical study was of a randomised, double blind, crossover design in a model of induced pain. The skin of healthy volunteers was carefully exposed to a controlled amount of ultra-violet light to increase the sensitivity of the skin to pain stimuli. The effect of the three products was assessed over a six hour time period post dosing using two criteria: the primary pain measurement was the volunteers' sensation of pain (heat pain tolerance test) and the secondary pain measurement was the level of inflammation (as indicated by erythema, reddening of the skin). The 60 subjects were divided into three cohorts of 20.
In the primary pain measurement, TPR100, whose active ingredient is the NSAID diclofenac, achieved statistically significant pain relief against placebo in both the 2% and 4% formulations. In addition, TIB200, whose active ingredient is ibuprofen, also achieved statistically significant pain relief against placebo.
The methyl salicylate and menthol product, SPR300, did not meet its primary endpoint in the primary pain measurement. This clinical study was looking primarily at the anti-inflammatory properties of the compounds rather than its established counter-irritancy properties.
Although the SPR300 arm of the study did not meet its primary endpoint, the robustness of this recent clinical study underlines Futura's commitment to developing compelling commercial products supported by evidence- based claims.
James Barder, Futura's Chief Executive, commented: "Meeting our primary clinical endpoints for pain relief for our NSAID gel formulations in these headline results is a substantial achievement in terms of moving our goal of regulatory approval closer, as well as assisting the commercialisation of both products. We intend to consult with regulators as soon as practicable to confirm the remaining requirements to obtain marketing authorisations for both products, as well as continue our dialogue with potential commercial licensees."
For further information please contact:
Aubrey Powell / Liz Yong / Thomas Smale
Tel: +44 (0) 20 7496 3000
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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.