In an exciting development for the medical cannabis industry, the NHS Research Ethics Committee has granted approval to Celadon Pharmaceuticals for the roll-out of a non-cancer chronic pain clinical trial. The trial, set to involve up to 5,000 patients, is a significant milestone for cannabis-based medicine in the UK.
Celadon Pharmaceuticals, a leading developer of cannabis-based therapies, and private pain clinic, LVL Health, will lead the trial. It is hoped that the new trial will help answer the call for more data from regulators and policymakers, which could help unlock wider access to cannabis-based medicines for chronic pain via the NHS.
The clinical trial approval followed an earlier conditional sanction by the Medicines and Healthcare Regulatory Agency (MHRA), contingent on a three-month feasibility study. The study, involving 100 patients with chronic pain conditions including fibromyalgia and arthritis, saw positive results for improving quality of life, sleep, and pain management while at the same time demonstrating a decline in the use of opioid medication.
Chronic pain affects up to 28 million people in the UK, and medical cannabis prescriptions in the UK are most commonly privately prescribed for chronic pain. The study, a collaborative effort with the MHRA, is designed to gather data to reinforce the case for cannabis-based medicine prescriptions and, in due course, enable potential reimbursement by the NHS.
In a noteworthy development, the trial will allow not just specialist physicians but also General Practitioners to prescribe medicine to trial participants, aligning with the ongoing advocacy efforts by Maple Tree, the Cannabis Industry Council, and Volteface.
Recruitment for the trial is expected to be facilitated through charities and other national organisations, allowing a broad range of patients to participate. While the specific details regarding recruitment procedures and criteria are yet to be announced, they are expected to surface soon to ensure the 'timely' roll-out of the trial.
Celadon chief executive, James Short, 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 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.”
This development symbolises a significant stride towards expanding the UK’s cannabis-based medicine market. More importantly, it signifies hope for patients dealing with chronic pain who are seeking alternative, effective treatment options. The approval by the NHS Research Ethics Committee underscores the growing recognition of cannabis-based medicines as a viable therapeutic option.