The approval involves the roll-out of a non-cancer chronic pain study for up to 5,000 patients
Celadon Pharmaceuticals, a company focused on the development of cannabis-based therapies, has announced that LVL Health, its private pain clinic, has been approved by the NHS Research Ethics Committee.
The approval involves the roll-out of its non-cancer chronic pain clinical trial for up to 5,000 patients.
Celadon has already received conditional approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for the commencement of the trial; however, the committee requested an initial feasibility study be undertaken over a three-month period.
Consequently, the results of the study were submitted for review in late 2022 and established positive outcomes for quality of life, pain and sleep, along with decreased opioid usage.
The research has been designed to create a data set that will support doctors’ prescriptions of cannabis-based medicines and, critically, potential reimbursement by the NHS and insurance companies.
Meanwhile, it will also allow GPs to prescribe the medicine to patients in addition to specialist doctors, and organisations, including charities, can advertise the trial in terms of recruitment.
Celadon believes these steps represent a significant advancement in enabling broader options for patients, leading to the widening of the UK cannabis-based medicine market.
James Short, chief executive officer at Celadon, was encouraged about the trial’s 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.”
He concluded: “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.”