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.
Topical diclofenac for the treatment of pain relief is widely available throughout the world without the requirement of a doctor’s prescription. Until recently topical diclofenac was only available with a prescription in the US, but in February 2020 it was switched by the US FDA to over the counter. This opens up a new commercial opportunity for TPR100 in the US and we will be working with our commercial advisers to understand the commercial opportunity this represents as well as with our regulatory consultants and the FDA to understand the requirements for approval in the US.
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. Under the terms of the agreement, Thornton & Ross Ltd will conduct the manufacturing scale-up of TPR100 and hold rights to manufacture, market and distribute the product in the UK for the lifetime of the product’s patents, which run to at least 2028 in the UK. Futura received an upfront payment and will receive a further milestone payment upon the product receiving UK regulatory marketing authorisation along with royalties on product sales.
In July 2018, Thornton & Ross Ltd submitted a product licence application to the Medicines and Healthcare products Regulatory Agency (MHRA) for the marketing authorisation of TPR100 in the UK. In February 2019, the MHRA responded to Thornton & Ross with a number of questions requiring additional laboratory work specifically around the permeation characteristics of TPR100 to be conducted. Futura has completed this additional laboratory formulation adjustment and work.
At a recent scientific advisory meeting with MHRA by Futura in conjunction with its commercial partner, the regulator recognised the improved skin permeation characteristics of TPR100 compared to market-leading diclofenac formulations. In vitro studies demonstrated that a 20% TPR100 dose relative to certain market-leading diclofenac formulations delivered the same permeation of active pharmaceutical ingredient through the skin. Due to this increased potency, a key differentiating characteristic for TPR100, MHRA now require data from a patient efficacy study with TPR100 in support of a marketing authorisation and are willing to consider superiority claims if the study is successful.
Since Voltaren® 1% has recently gained OTC status in the US a new and attractive potential market opportunity has arisen in that geography for TPR100.
Following the Medicines and Healthcare products Regulatory Agency’s (“MHRA”) request for a Phase 3 study to support the improved skin permeation and potential potency of TPR100 including potential superior efficacy claims, Futura has determined that the feasibility of a clinical study that would satisfy the Phase 3 requirements for both UK and US marketing approval will require a US distribution partner prior to the commencement of any Phase 3 programme.
The project is currently on hold as the company focuses its resources on its leading asset, MED3000.
Mid year to 2017, Nicholas Hall ‘s OTC Reports, Analgesics The Evolving Self-Care market for pain relief