In a groundbreaking development, Celadon Pharmaceuticals, a company specializing in cannabis-based therapies, has secured approval from the NHS Research Ethics Committee for its private pain clinic, LVL Health. The approval signals the commencement of a non-cancer chronic pain clinical trial, with a scope to include up to 5,000 patients.
Celadon had previously obtained conditional approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for the trial's initiation. However, the committee mandated an initial feasibility study spanning three months to be conducted.
The results of this study, submitted for review in late 2022, yielded positive outcomes in terms of quality of life, pain relief, and improved sleep patterns. Notably, the study also highlighted a reduction in opioid usage among participants.
The primary objective of this research is to establish a comprehensive data set that will empower doctors to confidently prescribe cannabis-based medicines to patients. Moreover, it aims to pave the way for potential reimbursement by the NHS and insurance companies, thus facilitating increased access to these therapies.
As a pivotal step forward, the approval will enable general practitioners to prescribe cannabis-based medicines alongside specialist doctors. Additionally, organizations, including charities, are now authorized to participate in trial recruitment initiatives.
James Short, the Chief Executive Officer at Celadon, expressed his enthusiasm about the approval: “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.”
Mr. Short emphasized the company's commitment to opening up the UK market by instilling confidence among doctors in prescribing cannabis-based medicines. The larger clinical trial, developed in collaboration with the MHRA, is strategically designed to create a robust data set that holds the potential for prescription and reimbursement by the NHS and insurance companies.
This milestone achievement is poised to revolutionize the landscape of chronic pain management and widen the availability of cannabis-based medicines in the UK. With Celadon's dedication to patient-centric solutions, the future holds promising prospects for transforming the treatment options available to those in need.