Celadon gets nod to start cannabis trial for pain in UK
Celadon Pharmaceuticals has secured the final approval needed to start a large-scale trial of its cannabinoid therapy for chronic pain in the UK.
The AIM-listed company said this morning that the NHS Research Ethics Committee had given the green light for the study in up to 5,000 non-cancer pain patients to get underway after it submitted the results of a three-month feasibility study.
The approval has been granted to LVL Health, Celadon's private pain clinic, on the strength of quality-of-life, pain and sleep data from the feasibility study, as well as evidence that subjects were able to reduce their use of opioid analgesics.
The study already had conditional approval from the Medicines and Healthcare products Regulatory Agency (MHRA), but couldn't get started without the Ethics Committee's decision.
Celadon said the trial is believed to be the first of its kind in the UK and will be used to create data that will support "prescriptions of cannabis-based medicines and, in time, enable potential reimbursement by the NHS and insurance companies."
The go-ahead for the trial follows the MHRA's good manufacturing practices (GMP) approval of Celadon's manufacturing facility in Birmingham as well as a Home Office license to supply cannabis products based on pharmaceutical-grade tetrahydrocannabinol (THC) – the first such license to be awarded since the government opened up the industry in 2018.
Previously, Celadon was only able to manufacture its THC oil, but the new approvals mean it can supply the product to specialist clinics with the right to prescribe medical cannabis, as well as to organisations carrying out R&D into THC-based therapies. Recently the company said that it expects to activate its first supply deals before the end of the year.
While private prescribing on a named-patient basis and supplying other companies will provide near-term revenues, getting approval for its THC oil as a treatment for chronic pain could be a game changer for Celadon.
So far, only a couple of cannabis-derived medicines have been cleared for widespread use by the NHS – Epidyolex for certain types of rare childhood epilepsy and Sativex for multiple sclerosis – both developed by GW Pharma which was acquired by Jazz Pharma for $7.2 billion in 2021.
There are an estimated 8 million people in the UK currently suffering from chronic pain, with opioid use rates among the highest in Europe.
"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 Celadon's chief executive James Short.
"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 added. "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."