Celadon Pharmaceuticals Plc announced last week that it has been approved to commence a unique non-cancer chronic pain clinical trial for up to 5,000 patients involving cannabis medicines.
Celadon’s private pain clinic, LVL Health, has received the green light from the National Health Service (NHS) Research Ethics Committee for the trial. Prior to this permission, the Committee had requested an initial three-month feasibility study. The results of which yielded promising outcomes in improving patients’ quality of life, pain, sleep, and in the reduction of opioid usage.
The trial will use an inhalation device from Ryah, which works with a mobile app to collect patient data in real time, and deliver a defined dose of medicinal cannabis at a pre-set temperature to ensure the usage and dosage is as prescribed.
LVL’s study was designed in collaboration with the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) to demonstrate the safety and efficacy of cannabinoids for chronic pain sufferers, and Celadon hopes it will provide a dataset enabling potential for prescription and reimbursement by the NHS and insurance companies.
“This is more important than ever given the significant problems and side effects seen with opioid treatments in recent years,” states the Celadon website.
Celadon CEO James Short was very pleased with the green light from the NHS Research Ethics Committee
“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,” said Mr. Short. “Everything we do at Celadon starts with the patient, and the results from the first part of the study have been tremendous.”
The company is working to finalise the plan for the rollout of the trial.
Celadon’s 100,000 sq ft UK facility has capabilities to address all aspects of medical cannabis manufacturing – from cultivation, to processing and creating active pharmaceutical ingredients. Earlier this year, Celadon announced its current Home Office licence had been updated to allow the commercial sale of its high Δ9-tetrahydrocannabinol (“THC”) product within the UK.
“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,” said Mr. Short.