Approval to roll-out chronic pain clinical trial
London, 1 August 2023 – Celadon Pharmaceuticals Plc (AIM: CEL), a UK-based pharmaceutical company focused on the research, cultivation, manufacturing and sale of breakthrough cannabis-based medicines, announces that LVL Health, its private pain clinic, has received approval from the National Health Service (“NHS”) Research Ethics Committee to roll-out its non-cancer chronic pain clinical trial for up to 5,000 patients (the "Trial").
The Company previously held conditional approval from the Medicines and Healthcare products Regulatory Agency ("MHRA") for the Trial, however before formally commencing the Trial, the NHS’s Ethics Committee requested an initial Feasibility Study to be conducted over a three-month period. The results of the Feasibility Study were submitted for review on 30 December 2022 (as announced by the Company) and indicated positive outcomes for quality of life, pain and sleep, as well as the reduction of opioid usage.
As an approved Trial, it is believed to be the only one of its kind in the UK, and is designed to create a data set that will support doctors’ prescriptions of cannabis-based medicines, and in time enable potential reimbursement by the NHS and insurance companies. It also enables General Practitioners to prescribe the medicine to patients in addition to specialist doctors, and organisations such as charities can advertise recruitment for the Trial. The Company believes this to be a major advance in enabling much wider access for patients, ultimately leading to the opening up of the UK market for cannabis-based medicines.
The Company is working with its partners to finalise the plan for the optimal and timely roll-out of the Trial.
James Short, Chief Executive Officer of Celadon, said:
“We are delighted that our clinical trial has received its approvals and we can now start the important work of getting our medicine to patients. Everything we do at Celadon starts with the patient, and the results from the first part of the study we have seen in terms of improvements in quality of life have been tremendous.
“Our longstanding aim remains to open up the UK market by giving doctors confidence in prescribing and creating the most robust data set to-date in the UK for cannabis-based medicines. This is why we invested in LVL and the trial protocol in the first place, which was over two years in development.
“This larger clinical trial was designed in collaboration with the MHRA to provide a data set that will enable the potential for prescription and reimbursement by the NHS and insurance companies.”
