If approved by the UK Medicines and Healthcare products Regulatory Agency, it would allow Huddersfield-based Thornton & Ross to make and sell the gel throughout the UK.
Thornton & Ross, a subsidiary of German group STADA, holds the exclusive rights to manufacture, distribute and market TPR100 in the UK until the product's patents expire in 2028.
“The filing of this marketing authorisation application marks a very important step in the commercialisation of TPR100 in the UK,” said chief executive James Barder.
“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.”
The plan is for TPR100, which gets to work quicker than most of its rival because of Futura's proprietary DermaSys delivery system, to be launched as an over-the-counter treatment for sprains, strains and bruises.
In clinical studies, the gel achieved “statistically significant pain relief” versus a placebo.