Regulatory Affairs

Futura Medical seeks UK approval for topical pain relief product

Published 23 July 2018

Futura Medical announced that its UK commercialisation partner for TPR100, one of the company's novel topical pain relief products, has filed the product's marketing authorisation application with the UK Medicines and Healthcare products Regulatory Agency.

TPR100 is licensed in the UK to Thornton & Ross, one of the UK's largest consumer healthcare companies and a subsidiary of STADA. Thornton & Ross holds exclusive rights to manufacture, distribute and market TPR100 in the UK for the lifetime of the product's patents, which run to 2028 in the UK.

TPR100, which benefits from the rapid skin permeation rates offered by Futura's proprietary DermaSys® delivery system, will be launched, once approved, as an over-the-counter and general sales ledger product for the local symptomatic relief of pain and inflammation in:

trauma of the tendons, ligaments, muscles and joints, e.g. from sprains, strains and bruises

localised forms of soft tissue rheumatism.

Futura has achieved statistically significant pain relief in a clinical study compared with placebo for TPR100, which is a non-steroidal anti-inflammatory drug ("NSAID") using diclofenac as its active ingredient.

Futura Medical chief executive James Barder said: "The filing of this marketing authorisation application marks a very important step in the commercialisation of TPR100 in the UK. We are delighted by the commitment to the product shown by Thornton & Ross and we look forward to the product's launch in due course.

"TPR100 has the potential to be a best-in-class treatment in which the topical formulation and efficacy profile very successfully meet patient needs. We continue in commercial discussions with several potential distribution partners for territories outside of the UK."

Futura Medical is a pharmaceutical group that develops innovative products for both prescription and consumer healthcare markets. The Company is developing a portfolio of products and its strategy is to license their manufacture and distribution to major pharmaceutical and healthcare groups.

Source: Company Press Release