Could Aussie cannabinoid companies help solve a global opioid crisis?
Health & Biotech
Health & Biotech
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In what has been widely described for some time now as an opioid crisis, governments globally are working to reduce the use of opioid pain relievers and associated addiction problems, and some ASX cannabinoid companies think they might just hold the key.
While associated with illegal drugs such as heroin, opioids have also long been used in medical settings to control acute and chronic pain.
According to the US Department of Health and Human Services (HHS) back in the late 1990s, pharmaceutical companies reassured the medical community that patients would not become addicted to opioid pain relievers, and healthcare providers began to prescribe them at greater rates.
However, increased prescription of opioids led to widespread misuse of both prescription and non-prescription opioids before it became clear that these medications could indeed be highly addictive. By 2017, the US had declared a nationwide public health emergency regarding the opioid crisis.
Back at home, according to Australian Institute of Health and Welfare research, legal or pharmaceutical opioids have been involved in more deaths and opioid poisoning hospitalisations than heroin. Over the past decade, opioid-induced deaths were more likely to be due to prescription than illegal drugs, while there has been a rise in deaths with a prescription drug present.
The total economic burden of prescription opioid misuse alone in the US is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.
While governments and the health sector work to tackle the opioid crisis, those involved in the medicinal cannabis sector also feel they can be part of the solution.
Cannabis as a medicine is not new, used by ancient civilisations including China, India and Egypt as a treatment for various illnesses. But increased recreational use and perceived harm to society meant it has been widely outlawed in many countries over the years.
However, as scientists discover new ways to use the plant’s medicinal compounds, medical cannabis is now one of the world’s fast-growing industries. Spend on legal cannabis is forecast to be worth more than US$60 billion by 2024, as regulations around the world start to catch up with the demand.
Research is mixed as to whether medicinal cannabis will actually fix the opioid crisis and be a viable alternative to pain management. A study published in Health Economics found that the implementation of recreational marijuana laws in 2017 in four US states was associated with a decline in opioid-related emergency department visits, but the decline did not persist after six months.
Guidance for the use of medicinal cannabis in the treatment of chronic non-cancer pain in Australia by the Therapeutic Goods Administration (TGA) provides comprehensive findings of medicinal cannabis for differing conditions and is updated as new evidence emerges.
Australia is seen as one of the progressive countries when it comes to the medicinal cannabis sectors. In 2020 a significant change in Australia’s medicinal cannabis market occurred when the TGA regulations changed to allow medicinal cannabis products to be sold as an over-the-counter medicine under the TGA’s S3 schedule.
Medicinal Cannabis is currently only available under the SAS-B scheme, where patients must obtain a prescription from a registered doctor (S4 medicinal cannabis product).
One ASX cannabinoid company interested in working to tackle the opioid crisis is Medlab Clinical (ASX:MDC)
Medlab has two cannabinoid products available under the Australian Special Access Scheme (SAS) – NanaBis (1:1 THC:CBD) and NanoCBD (CBD only). Both are enhanced by Medlab’s patented nano-particle delivery technology, NanoCelle, which uses an intra-oral spray to the oral buccal muscosa inside the cheek, bypassing the first pass metabolism (liver and gut) claiming to deliver medicines more effectively with faster onset of action and reduced side effects.
NanaBis has completed Phase 1 and Phase 2 clinical studies and is preparing a Phase 3 study. Ongoing observational studies have shown both NanaBis and NanoCBD to have significant results in pain management, quality of life improvements, and opioid sparing.
“Obviously opioids work and have their place in medicine, however regulatory bodies are working with industry to find better analgesic-type therapies; right now Nabilone (brand name Cesamet) is interesting as are opioid reduction therapies. So it’s clear we are all looking for better or improved non-opioid analgesics,” Medlab’s CEO Dr Sean Hall told Stockhead.
He said efficacy, sustainability and safety are always going to be the critical features in any new drug application, so any candidate to reduce or replace opioid use must be supported by robust CMC (chemistry, manufacturing and controls) packages, clinical trials, and data points that support sustainable and safe long term use – and this would need to be wrapped up in a final product that receives regulatory approval.
“Medlab today has over 1100 Australians who have been using our investigative product NanaBis; as a result we have been able to safely and ethically collect multiple datapoints that speak to opioid sparing capabilities, significant pain reduction and improvements to quality of life, and very importantly to sustainability beyond 12 months with minimal to no adverse effects,” Hall said.
“Coupled with the CMC and clinical work done to date, Medlab has strong expectations for NanaBis moving forward into Phase 3 trials, and as a potential candidate to assist with the global opioid crisis.”
While there are more than 40 stocks on the ASX that are into cannabis to varying degrees, here’s a list of other ASX biotechs involved in research and development of cannabinoid products.
Althea has a range of 20ml full-spectrum CBD oil products for patients. Its best-selling product, Althea CBD100, is a full-spectrum oral oil product that it’s been selling in Australia since 2019 under the special access scheme for medicinal cannabis.
The company said the TGA’s move to increase the limit to 150mg is transformational, and fits its product range perfectly.
Multiple cannabinoid products in portfolio including CanQuitO – a patented chewing gum that combines cannabinoids and opioid antagonists to treat opioid addiction.
In an approach similar to Medlab’s NanoCelle nano-particle delivery platform, APIRx also uses an oral mucosa delivery method – in their case medicated chewing gums (MCGs) – to bypass the first pass metabolism (liver and gut).
Amongst 22 active clinical and pre-clinical R&D projects, APIRx are also investigating cannabinoid treatments for pain and spasticity related to MS.
Zelira has been working to expand its portfolio of cannabinoid-based products that target chronic pain.
The company believes there’s clear potential to use cannabinoids to reduce the use of opioids in patients requiring chronic pain management.
Zelira Therapeutics has partnered with St Vincent’s Hospital and Emyria (ASX:EMD) to study the effect of cannabinoid medications on people who are dependent on high doses of opioids to manage their chronic pain.
The successful results of the Phase 1 clinical trial found that treatment with cannabinoid-based medicine was well tolerated with no serious adverse effects. Additionally there was a dose–responsive improvement in subjective measures of pain, stress, anxiety and depression.
Bod has just completed a proof of concept study into the safety and efficacy of a cannabigerol (CBG).
CBG is a dominant cannabis extract which has shown very promising results in the clinic.
Preliminary research has indicated that CBG has unique pharmacological actions and has the potential to address alternative therapeutic areas to THC and CBD.
The study will form the basis for the launch of a new medicinal cannabis product that will be sold under Bod’s existing medicinal cannabis brand as MediCabilisTM CBG 50, which is expected this month.
Meanwhile, the first patients have been enrolled in Bod’s Phase IIB clinical trial on the use of CBD formulations to treat insomnia.
The trial is being undertaken with Woolcock, Australia’s leading sleep research organisation, and will study 200 participants over eight weeks.
A successful trial could see Bod bring a new product to the market under the TGA’s Schedule 3 market, which means it can be sold over-the-counter by a pharmacist to consumers without a prescription.
Emyria announced in May that EMD-RX5, its ultra-pure CBD capsule, has demonstrated excellent bioavailability and dose delivery profile in the Phase 1 study.
The Phase 1 pharmacokinetic crossover study with Epidyolex, which is the only TGA and FDA registered CBD medicine to treat psychological distress, showed excellent safety and tolerability with no gastrointestinal upset or adverse events at test dose of 150mg.
The study also showed that EMD-RX5 has equivalent bioavailability to Epidyolex, and twice the bioavailability compared to other, plant-derived CBD products with published pharmacokinetics data.
Apart from psychological distress, EMD-RX5 is being studied for multiple other indications.
Creso develops cannabis and hemp-derived therapeutic, nutraceutical and lifestyle products for both people and animals. The company has appointed Canadian Bruce Linton, whose name is synonymous with the global nascent medical-cannabis sector, as a non-executive director.
By partnering with global companies in critical areas of research and product development, manufacturing and distribution, Creso is working to accelerate the development and distribution of approved products allowing for broad access by patients and consumers.
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At Stockhead, we tell it like it is. While Creso Pharma, Medlab and Incannex are Stockhead advertisers, they did not sponsor this article.