TPR100 is a gel to provide topical pain relief. The product incorporates a non-steroidal anti-inflammatory drug ("NSAID") diclofenac and utilises Futura's DermaSys® technology.
Our unique transdermal technology - DermaSys®
Futura has developed a highly efficient and proprietary delivery technology, DermaSys® for the absorption of active molecules through the skin. DermaSys® is a versatile and bespoke technology in that it can be tailored to suit the specific active compound being used and the therapeutic indication. Such targeted delivery offers an optimised profile in terms of dose, onset time and duration of effect as well as an improved safety profile reducing the risk of side effects due to a lower systemic uptake.
Market-leading clinical trial results
Early completed in vitro and in vivo studies showed significant superiority in terms of skin penetration of the diclofenac molecule for TPR100 compared with other commercially available products. These studies showed that TPR100 achieved up to 40 times higher bioavailability than those achieved by other commercially available products with none of the side effects which can be seen with oral NSAID products.
In a recent randomised, double blind, placebo and active-controlled, crossover clinical study to assess the efficacy and safety against both a market-leading diclofenac gel, oral diclofenac and placebo gel, TPR100 achieved its primary efficacy endpoint against placebo and none of the comparator products, topical or oral, outperformed TPR100.
Our objective is for our products to be "best-in-class" against other comparable topical products. The rationale for this is that the National Institute for Health and Care Excellence (NICE) gives clear guidance to healthcare professionals to prescribe topical NSAIDs in the first instance for joint pain associated with osteoarthritis, in preference to oral NSAIDs, owing to concerns over systemic side effects caused by the long term use of oral NSAIDs.
We are carrying out the remaining development work with a target submission date for regulatory approval in the UK in the second half of 2017. In 2016, we retained advisors to assist in the out-licensing of TPR100. Both TPR100 and TIB200 have attracted considerable interest from major pharmaceutical and consumer healthcare companies. In January 2017 we announced the first licensing agreement for TPR100 to Thornton & Ross Ltd for the UK. Thornton & Ross, which was acquired by STADA three years ago, is one of the largest consumer health companies in the UK. We anticipate signing further potential regional licensing deals in 2017.
Protecting our IP
Futura has both granted patents and a number of further patent applications in relation to its DermaSys® technologies providing protection to at least 2028.