In a global first, a clinical trial using an Australian medicinal cannabis oil may offer hope to millions of Australians living with chronic neck and back pain, with the tested product showing a 38 per cent median reduction in pain. Importantly, there were also significant functional improvements in mood, enjoyment of life and walking for patients living with chronic neck and back pain.
‘Globally, this is the first phase II clinical trial specifically on chronic neck and back pain that shows statistically and clinically significant results using medicinal cannabis,’ said Clinical Professor Richard Chye, pain specialist at St Vincent’s Hospital and medical advisor to the study.
‘While cannabis has been used for pain relief, this is an important leap forward in strengthening the clinical evidence and safety for the treatment of chronic pain with medicinal cannabis,’ he said.
Peer reviewed and published in the Medical Cannabis and Cannabinoids journal, the trial examined adults over a four-week period with moderate to severe chronic back and neck pain who were unresponsive to over-the-counter analgesics. The study examined the optimal dose, pharmacokinetics, efficacy, safety, and tolerability of Cybis® THC:CBD oil.
Participants had been suffering chronic pain for a median of about 10 years. Almost all (93 per cent) had a history of prior analgesic use.
Overall, the results showed that Cybis oil was well tolerated and clinically effective in treating chronic pain, with participants reporting a 38 per cent median reduction in numerical pain scores.
Unique study
In a field dominated by studies involving adding trial medication to existing standard of care, this study is unique for its focus solely on assessing medicinal cannabis and its effects in isolation, setting it apart from the majority of research.
‘Cybis produced statistically and clinically significant pain reduction in moderate to severe chronic neck or back pain,’ said Professor Chye.
‘It was well tolerated with the majority of adverse events being of a mild nature. Pain reduction was dependent on the dose, with all doses showing significant reductions in pain. The higher the dose, the greater the pain reduction,’ he said.
Results showed that depression, anxiety and stress were all reduced, and there were also significant improvements in general activity, mood, walking ability, work, relationships and enjoyment of life. 74 per cent of participants expressed a desire to receive the treatment again at the end of the study.
To put these results in context, pharmaceutical opioids are now responsible for far more deaths, poisoning and hospitalisations in Australia than illegal opioids such as heroin. Every day in Australia, nearly 150 hospitalisations and 14 emergency department admissions involve opioid harm, and each year over 1,100 people die from drug-induced deaths involving opioid use.
GP Andrew Moore says, ‘Treating patients with chronic back and neck pain is challenging, particularly when pharmacological options are limited. Given this, and the problems with opioid use, this research is an important step towards safely using a novel treatment.
‘While medicinal cannabis is not for everyone, and there is much still to learn, I hope it will benefit many people suffering from chronic pain,’ he said.
Cybis is a solution formulated specifically for chronic pain patients by Australian biotech firm Cymra Life Sciences. Based in the Northern Rivers of NSW, they are the only Australian cultivator of medical cannabis that organically grow their own product in living soil.
Huge global demand
Joel Hardy is the CEO of Cymra Life Sciences. ‘Chronic pain is arguably the fastest growing medical condition in the world,’ he said, ‘impacting over 3 million Australians and costing the economy over $73 billion per annum – with costs predicted to continue to rise.
‘Due to this, the demand for quality medicinal cannabis in Australia and globally is exploding,’ said Mr Hardy.
‘The number of active medicinal cannabis patients in Australia has increased from almost zero in 2018 to 122,000 in 2021, with numbers estimated to increase to 670,000 by 2030. The TGA has given more than 250,000 approvals since 2016 under the most commonly used SAS-B pathway. Almost half of these were given just in 2021. Around 60 per cent of the approvals are for chronic pain,’ he said.
‘The market for chronic pain is about $104 billion worldwide, and there is a huge unmet need in treatment options, particularly given opioids are restricted by regulatory bodies and have long term side effects. We see cannabis as second line therapy prior to opiates that can really help to solve that problem,’ said Mr Hardy.
‘These positive study results give Cymra Life Sciences the confidence to proceed to a Phase 3 study with Cybis and subsequent submission for approval by global regulatory agencies such as TGA,’ he said.
Big numbers
Cymra says the market value in Australia for medicinal cannabis in predicted to 290 million in 2023. This is expected to increase to $1.35 billion by 2032.
‘Due to unprecedented demand, we are currently tripling size of our greenhouse and building a new processing facility so that we can increase production capacity by over 200 per cent over the next 2 years,’ said Mr Hardy.
Nicolette Ellis, President of Chronic Pain Australia, said ‘Medicinal cannabis is a highly sought treatment for chronic pain and some people with chronic pain have exceptional benefits.
‘Treatment can be difficult to access and very unaffordable. Of the hundreds of thousands of applications to Australia’s medicines regulator for special access to medical cannabis, chronic pain is the top reason given, which shows the desperation from the chronic pain community to find treatment for relief,’ she said.
The published study can be accessed here. You can find out more information about Cybis here.
Case studies
Paddington NSW: Felicity, 75-year-old retired social worker and music teacher. In the 1980s Felicity experienced a sudden decline in her health after being perfectly well. She faced a strange illness, lasting three years, characterised by polymyalgia, joint pain, and bone weakness.
Eventually recovering, Felicity later developed signs of neuropathy, causing widespread pain and difficulty walking. She was eventually diagnosed with Sjogren’s syndrome, an autoimmune disorder. Seeking relief, Felicity discovered that cannabis oil provided some respite from her severe night-time pain, helping her to cope better living with pain.
Camperdown NSW: Isabel, a 69-year-old Camperdown resident, was diagnosed with Parkinson’s disease in 2007, which has progressively worsened. She experienced a decline in January 2022 and was hospitalised due to extreme sciatic pain. Conservative treatments initially helped but eventually failed, leading to three back surgeries, including spinal fusion.
A few months later, Isabel was diagnosed with Pisa syndrome, an uncommon condition possibly triggered by the surgeries. The deviation in her spine causes painful truncal bending to the right and facing the ground. She is generally unable to return to an upright position without pushing her weight through her arms and relies primarily on a walker to do this.
Isabel experiences different types of pain, with neuropathic pain being controlled but muscular pain being difficult to relieve. She also struggles with sleep issues.
To manage the muscle spasms associated with Pisa Syndrome, she started using cannabis oil (Cybis) about seven months ago. The cannabis oil has also improved her sleep from 3-4 hours per night to 6 hours.
Brisbane QLD: Kevin James has lived with chronic pain since 2009 and gave up his career as a full-time occupational health consultant due to crippling lower back pain.
Kevin was one of the first people to be approved to use medicinal cannabis in 2018. He hopes that continued research into medicinal cannabis for chronic pain will improve treatment options.
Mr James said: ‘For me, medicinal cannabis has improved my quality of life by aiding sleep and reducing my need for other pain medication. Research such as this is incredibly important to improve the knowledge base regarding medicinal cannabis for chronic pain to be able to more effectively tailor treatment to individuals.
‘It also helps to reduce the stigma,’ he said.
