The pharmaceutical company has spent time focusing on the research, cultivation, manufacturing, and sale of breakthrough cannabis-based medicines, and now has approval to roll out its trial for up to 5,000 patients.
The company previously held conditional approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for the trial, however before formally starting, the NHS ethics committee requested an initial feasibility study to be conducted over a three-month period.
The results of the study were submitted for review on December 30, last year (2022) and indicated positive outcomes for quality of life, pain, and sleep, as well as the reduction of opioid usage.
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.”
The company says that as an approved trial, it believes it 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.
Celadon says it also enables GPs 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.
“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.
Short added: “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.”
Celadon working with its partners to finalise the plan for roll-out.
The trial uses a leading inhalation device which is connected to a mobile app to collect patient data in real time and deliver a defined dose of medicinal cannabis at a pre-set temperature which is to ensure the usage and dosage is as prescribed by doctors. The medicinal cannabis product inside the cartridge is high quality, consistent and made to GMP standards. Patients have access to LVL’s specialist pain doctors and 24/7 clinic access.