Do you really believe it doesn’t have any peers GC?
Take the English company Futura Medical. Which is a little transdermal company not dissimilar to POH.
In 2011 it published a paper showing that its DCF100C formulations facilitated greater
diclofenac penetration through the skin.
The company claims: “TPR100 has been shown to achieve in excess of eight times higher permeation through human skin and 35 times greater bioavailability than that achieved by the UK’s bestselling topically applied diclofenac based pain relief product, Voltaren® gel at a similar 1% diclofenac w/w concentration.
It hopes through further trials that this increased penetration and bioavaibality will result in superior efficacy but this remains to be tested. So what comes next? Test that.
Just recently it started a complex RCT in an induced pain design with healthy volunteers across its three topical pain products diclofenac, ibuprofen and methyl salicylate. The study is described as follows:
“Futura Medical plc announced 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.”
Quite a clever design – but complex. Designed to test the key issue here. Its not difficult to show higher permetation and greater bioavailability. The question is how this translates into clinical efficacy. Up against the reference topical – but also the oral version.
So non-inferiority (on clinical parameters speed of onset etc) for regulatory approval but the possibility of superiority to support the marketing claims.
POH is still at the level of the 300% more penetration stuff. There is no RCT of anything. Is the POH gel actually able to be approved in the US – Australia – UK?
Positive results from Futura in July and you have some admittedly not perfect “clinical efficacy” results because its in a induced pain model but some pretty good marketing claims.
Maybe don’t rush out and buys shares in them. A glance of the yearly share price shows a trend nearly as bad as POHs.
POH Price at posting:
3.3¢ Sentiment: None Disclosure: Not Held
(20min delay)