A clinical trial investigating the efficacy of cannabis-based medicines in up to 5,000 patients with chronic pain has been given the green light from UK regulators.
Celadon Pharmaceuticals, a licensed producer of cannabis-based medicines in the UK and is private pain clinic, LVL Health, have received approval from the NHS Research Ethics Committee to roll-out its non-cancer chronic pain clinical trial for up to 5,000 patients.
Celadon previously held conditional MHRA approval for the trial on the basis of a three-month feasibility study.
Results of the study, conducted in 100 patients, indicated positive outcomes for quality of life, pain and sleep, as well as the reduction of opioid usage.
Up to 28 million people in the UK are thought to be living with some form of chronic pain, with some 14,000 people diagnosed annually with hard-to-treat pain conditions such as fibromyalgia.
Chronic pain is the most common indication for which cannabis medicines are currently prescribed privately, but regulators and policymakers have repeatedly called for more robust data before they can be routinely prescribed for pain through the NHS.
The full clinical trial, which is thought to be one of the first of its kind in the UK, is believed to have been designed in collaboration with the MHRA and aims to create a data set to support the wider prescription of cannabis-based medicines, and in time enable potential reimbursement by the NHS.
GPs, in addition to specialist doctors, will be permitted to prescribe the product to participants enrolled on the trial and patients will be recruited through charities and other national organisations.
Details of recruitment procedures and criteria are expected to be announced in the near future to ensure the ‘timely’ roll-out of the trial.
Announcing the news in a press release Celadon describes it as a ‘major advance in enabling much wider access for patients’.
Chief executive officer, James Short, commented: “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.
“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.
“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.”
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The post NHS approves major clinical trial on cannabis medicines and chronic pain appeared first on Cannabis Health News.
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Author: Sarah Sinclair
