TPR100 will provide topical pain relief. The product incorporates a non-steroidal anti-inflammatory drug ("NSAID") and utilises Futura's DermaSys® technology.
Futura has developed a highly efficient and proprietary delivery technology, DermaSys®, for the absorption of active molecules through the skin. The DermaSys® technology was originally developed for use in our topical treatment for erectile dysfunction, MED2002. 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 through lower systemic uptake and the reduced risk of side effects.
We have completed a clinical study that showed significant superiority in terms of skin penetration of the NSAID molecule for TPR100 compared with the commercially available, market-leading product. Clinical tests carried out by Futura have shown that TPR100 achieves between 30 to 40 times higher bioavailability than those achieved by the market-leading product with none of the side effects which are seen with oral NSAID products.
We have previously consulted with relevant regulatory authorities and believe the regulatory pathway for TPR100 in a number of key commercial territories is relatively straightforward as the active compound is well-characterised and has already been approved in both oral and topical form for the indication of pain relief. The minimum requirements to satisfy EU regulators are likely to comprise a small Phase I trial to demonstrate a lack of skin irritation or sensitisation and a Phase III trial to demonstrate non-inferiority to the market-leading product in topical pain relief. Based on our research and development programme so far we remain confident of obtaining positive outcomes to these studies, which we expect will be funded by commercial partners.
TPR100 is currently under evaluation with a major pharmaceutical company until the end of June 2010. This evaluation may, or may not, result in a commercialisation agreement for rights to TPR100 in certain territories.
TPR100 utilises our skin delivery technology
