Targeting a large potential market with unmet medical need

  • Global sales of topical over the counter non steroidal anti-inflammatory drugs (“NSAIDs”). US$ 2.9 billion1
  • US market alone worth over $1bn2.
    1st product launched in the US in 2008.
  • Demand for safe, effective and long lasting topical pain relief. Topical treatments are first line of treatment for osteoarthritis of the joints.
  • DermaSys® provides faster drug permeation, a key point of difference. 

Topical NSAIDS treatments are recommended by the National Institute for Health and Care Excellence (NICE) as the first line treatment 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.

Commercial strategy

TPR100 is partnered for manufacturing and distribution in the UK with Thornton & Ross, one of the UK’s largest consumer healthcare companies and a subsidiary of STADA AG. In February 2019, the UK Medicines and Healthcare products Regulatory Agency (MHRA) responded to Thornton & Ross’s marketing authorisation application filed in July 2018, with a number of questions requiring additional laboratory work specifically around the permeation characteristics of TPR100 to be conducted. This work is progressing but requires further laboratory formulation adjustment and in vitro studies to enable TPR100 to meet the strict criteria established by the MHRA and thereby avoid the need of a Phase 3 pain relief efficacy study. It has delayed the response to MHRA by at least six months to accommodate this regulatory approach.  Futura is awaiting regulatory authorisation in the UK before progressing further with licensing discussions for further regions. 

  1. 2015 IMS Health Estimate
  2. 2015 IMS Data source