A SHEEP pain relief product developed in Australia has been approved for clinical trials for human use in the United Kingdom.
Tri-Solfen® was developed in Australia by Animal Ethics Pty Ltd, a wholly-owned subsidiary of human and animal pain mitigation company Medical Ethics.
Tri-Solfen® was first designed to adhere to wounds to provide rapid onset numbing with prolonged analgesia effects for sheep. It is widely used in Australia as a post-operative topical spray on sheep after mulesing. The local anaesthetic and antiseptic gel also contains active ingredients designed to minimise bleeding, protect against infection, coat wounds and promote healing.
Medical Ethics announced today that the UK’s Medicines and Healthcare products Regulatory Agency has approved its application for a Phase IIa clinical trial of Tri-Solfen®, under the human product brand Medi-Solfen®, for the treatment of pain during the surgical debridement of venous leg ulcers. Medical Ethics said Medi-Solfen® is its lead product candidate for human use and is designed to provide rapid onset, and short and prolonged analgesia effects for up to 24 hours. The company anticipated initiating the clinical trial in first quarter of 2019.
The Phase IIa clinical trial will assess the safety and efficacy profile of Medi-Solfen® in providing anaesthesia when applied topically to venous leg ulcers, before and after surgical debridement. The open, randomised, parallel group-controlled study will be conducted in 90 patients in three successive stages, which aim to study the time taken to achieve surface anaesthesia, degree of post-operative pain relief and patient’s assessment of overall quality as an anaesthetic during this procedure. Secondary objectives include the duration and quality of post-operative pain relief following a single-dose, levels of anaesthesia achieved, and influence on the early healing trajectory of the leg ulcer.
Medical Ethics managing director Allan Giffard said the approval is an important milestone for Medical Ethics as its first product candidate for human use progressed for clinical development as the company moved towards building a proprietary wound care and pain mitigation platform.