UK’S NHS Approves Full-Scale Roll-Out of Medical Cannabis Clinical Trials
The United Kingdom’s National Health Service (NHS) Research Ethics Committee has approved the full-scale rollout of a new clinical trial into medical cannabis and non-cancer chronic pain.
This report first appeared in the Business of Cannabis on 2 August 2023.
AIM-listed medical cannabis company Celadon Pharmaceuticals announced on Tuesday, 1 August 2023, that its subsidiary has now received the green light to launch its Canpain trial, after receiving ‘conditional approval’ from the MHRA (Medicines and Healthcare products Regulatory Agency) last April.
The news marks the latest in a string of promising medical cannabis research developments from UK companies in the last month, as the industry continues its slow but steady campaign to expand access for patients, with the ultimate goal of achieving NHS reimbursement.
Momentum has continued to build
In January, Business of Cannabis reported that the UK’s medical cannabis industry had wasted little time in shaking off the stagnation experienced in 2022 as the country’s leading cannabis companies released a flurry of updates.
This momentum has seemingly continued to build throughout the year, coinciding with the continued growth of private prescriptions.
According to a recent FOI request, the number of private prescriptions between January and September 2022 hit 68,556, an increase of 171% on the same period a year earlier, and more than the total 43,927 prescriptions seen in 2021.
In January, similar data suggested that the total number of prescriptions between November 2018 when medical cannabis was legalised in the UK and July 2022 was 89,239.
The more recent data, which was reportedly last updated on June 14, suggests the total number of prescriptions between November 2018 and September 2022 was 117,226, an increase of 27,987.
It’s worth noting that pharmacies are not required to send this information to the NHS straight away, resulting in a significant lag in accurate data. This can see figures updated well over a year after they were initially reported.
Regardless, it points to steady and consistent growth in private medical cannabis prescriptions, with July 2023 seeing prescription numbers top 10,000 for the first time.
Celadon’s subsidiary LVL Health has now reportedly received approval to launch its non-cancer chronic pain trial in full, enabling up to 5,000 patients to take part.
In April last year, Business of Cannabis reported that after it received ‘conditional approval’ from the MHRA, the Research Ethics Committee had called on LVL to complete a smaller ‘feasibility study’ before the larger study was approved.
In July 2022, the company officially began the onboarding of patients for the feasibility stage of the trial, aimed at providing evidence of patient interest in the study before granting approval for a far larger trial of up to 5,000 patients.
James Short, Celadon’s CEO, said at the time that the process so far had ‘been slow’, which he attributes to a much stronger than expected patient response, after widespread press attention led to thousands of applications.
Following the three-month feasibility stage, the results were submitted for review on 30 December 2022, and indicated positive outcomes for quality of life, pain and sleep, as well as the reduction of opioid usage.
Now the green light has finally been given, Celadon says it is ‘working with its partners to finalise the plan for the optimal and timely rollout of the trial’.
Mr Short said: “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.”
It came just days after LSE-listed Oxford Cannabinoid Technologies (OCT) announced that the ‘first-in-human dose’ of its lead pharmaceutical drug compound had now been successfully administered as part of its Phase 1 clinical trial, with results expected in Q3 2023.
This came two months after OCT announced that it had finally secured MHRA approval for its Phase 1 clinical trials for its lead compound, which has shown potential as an effective therapy for chemotherapy-induced peripheral neuropathy (CIPN) and IBS.
Last month, OCT also announced plans to break into a new area of research after identifying a potential ‘first in class’ immunotherapy treatment for solid tumours, suggesting this treatment could be ‘much, much more cost-effective from a healthcare provider point of view’, with plans to commence trials ‘as soon as we can’.
In the same week Ananda Developments revealed that its wholly owned subsidiary MRX Medical Limited (MRX) had launched its first two cannabinoid medicines MRX1 and MRX2 onto the unlicensed medicinal products market.
The former compound, MRX1, is a CBD formulation that was recently approved for two Phase II clinical trials in the UK with £1.55 million of grant funding.
The trials are thought to be the first two cannabis randomised control trials (RCTs) in the UK since GW Pharmaceuticals’ trials for Epidyolex and Sativex, and Ananda says it is ‘very hopeful’ that its product could soon be funded for prescription on the NHS.
Ananda’s CEO, Melissa Sturgess, commented: “We are determined to win NHS support for our cannabinoid medicines with our rigorous approach to formulation development, clinical trials and traditional pharmaceutical data collection. We believe that MRX is in the strongest position to do exactly that. With NHS endorsement we can bring these medicines to the millions of people who need them and deliver revenues to Ananda.”