Business
TPR 100: UK Regulatory Submission
TPR 100: UK Regulatory Submission.
About this update from Futura Medical Plc
[{"type":"text","content":"\n \nRNS Number : 4026V Futura Medical PLC 23 July 2018 \n\n\n\n\n\nFor immediate release \n\n\n 23 July 2018\n\n\n\n\n \n \n \n \n \n \n \nFutura Medical plc\n(\"Futura\" or the \"Company\")\n \nTPR100: UK Regulatory Submission \n \nFutura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce 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.\n \nTPR100 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.\n \nTPR100, 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:\n· trauma of the tendons, ligaments, muscles and joints, e.g. from sprains, strains and bruises\n· localised forms of soft tissue rheumatism.\n \nFutura 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.\n \nJames Barder, Chief Executive of Futura Medical, 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.\n \n\"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...