For thousands of years, novel medicines have been used by humanity and been manufactured by major pharmaceutical companies in the 20th Century. However, vested interests in the paper, cotton, pharmaceutical and plastics industry, as well as racist elements in law enforcement, colluded to prohibit certain types of these medications, for their own financial gain.
Now, these drug therapies are again being used to promote health and reduce harm (compared with poly-pharma, alcohol and nicotine use). Promethean BioPharma is proud to be at the forefront of this revolution that could transform the way health professionals approach patient care and treatment, as well as the way society relaxes.
Compounds such as MDMA (Methylenedioxymethamphetamine) also known as ecstasy, kratom, ketamine (anaesthesia medication), and psilocybin (magic mushrooms) are currently undergoing clinical trials in the hope that they may join medicinal cannabis as one of the many novel medicines that provide patients with greater choice in, and access to treatment for some of the world’s most costly and intractable diseases.
The power of novel medicines
Medicinal cannabis is a prime example of the potential of novel medicines. Despite cannabis having a long history of treating a range of disorders, it has only been in recent years, after many clinical trials, that medicinal cannabis has again been recognised as an efficacious and beneficial medicine, far less toxic than many alternatives and is therefore returning from prohibition to mainstream use. Now, an increasing number of countries have legalised medicinal cannabis, including Australia, with doctors around the world prescribing it for over 100 medical conditions.[1]
Researchers have now added other compounds traditionally used for recreational reasons, in the hope that they may unlock cutting-edge treatments that benefit both doctors and patients. Promethean BioPharma is privileged to be involved in such a dynamic industry and is excited by the initial results of these clinical trials. Studies showing significant promise are those involving psychedelic drugs.
Psychedelic drugs could unlock new therapies
Currently, psychedelic-assisted psychotherapy focusing on psilocybin and MDMA is being trialled worldwide with initial results providing hope that they may be effective treatments for depression, anxiety, PTSD and addiction. New trials are also underway to examine whether these novel medicines can treat anorexia and dementia.
Psilocybin (found in ‘magic mushrooms’) has been used for centuries in different cultures for spiritual and religious purposes, as well as for recreational use. Now researchers are investigating how high-quality, controlled dosing of this compound can affect the brain.
Initial reports from clinical studies indicate that psilocybin changes an individual’s perception and feeling of connectedness to others, the world and themselves, which may help patients address issues of underlying disconnection present in many health disorders.[2] Trials looking at how psilocybin can assist with issues of addiction have also shown favourable results.[3] [4]
Similarly, there is growing evidence that using MDMA combined with psychotherapy may help patients with PTSD, for whom current treatments have not been effective. [5] Initial research indicates that MDMA may assist with psychotherapy as it reduces defensiveness and anxiety, improves mood, and increases relaxation as well as the bond between patient and therapist.[6] This means patients may be more able to relive traumatic events and work through them without being re-traumatised or being too overwhelmed.
Hope for those with mental illness
As a result of the COVID-19 pandemic, there has been a dramatic rise in the prevalence of mental health problems around the world. Globally, it’s estimated that 28.0% have depression, 26.9% have anxiety and 24.1% exhibit post-traumatic stress symptoms.[7] Experts predict that the mental effects of the pandemic will continue to rise and be felt for years to come. Therefore, we must find new approaches in treatment to reduce both the prevalence and cost of mental illness. It’s also important that these therapies are safe and effective.
Existing treatments for psychiatric conditions have a success rate of 30% to 35%.[8] These medications often need to be taken for a long time to be effective, can cause unwanted side effects, or be difficult to wean off.
However, international trials using psilocybin and MDMA to treat depression and PTSD have shown a success rate of 60% to 80%.[9] They have also been shown to be fast-acting treatments that are very safe and non-addictive when used in a medically controlled environment.
Promethean BioPharma is a powerful mix of professionals in regulatory access, manufacturing, logistics, business administration and medicine and we are excited about sustainably supporting the future of novel medicines and the difference they can make to patients. We are particularly excited about the ground-breaking work our key partners are involved in and the differences that we can make to improve the sustainability of health economics.
A snapshot of the future
MYND Life Sciences, a leading company focusing on developing psychedelic drugs and pharmaceuticals to improve mental health, led by Promethean BioPharma Board member, Dr Lyle Oberg, is currently investigating whether novel psychedelic drugs including psilocybin can treat depression and other central nervous system disorders.
The signing of a Collaborative Research Agreement with the University of British Columbia sets the foundation for the development of novel therapies using psilocybin and other compounds to treat Major Depressive Disorder (MDD), also known as depression. This research is further enhanced by a partnership with a private vaccine developer, to develop vaccines that can prevent neurological disorders such as MDD. They are also working on methods for treating or delaying Alzheimer’s disease and other related forms of dementia, using psychedelic drugs.
Another key player in this exciting frontier of medicine is Mind Medicine Australia, a registered charity founded by Tania de Jong AM and Promethean BioPharma Board Member, Peter Hunt AM. Mind Medicine Australia connects clinicians, consumers, academia, government, industry, regulatory bodies, philanthropists, and investors, and seeks to establish best-practice in regulated psychedelic-assisted treatment.
Subject to results from Phase 3 clinical trials underway overseas, Mind Medicine Australia is preparing to assist the Australian health care system for possible regulatory changes to enable the use of these psychedelic therapies, by supporting clinical research, and developing a clinical implementation framework and therapist training protocols.
They are also working tirelessly to educate and engage relevant stakeholder groups to raise awareness of the potential of psychedelic-assisted treatments.
An exciting frontier in the medicine of the future
Advancements in science, research, and technology will continue to change the way we define illness and disease, develop medicines and prescribe treatments. In order to bring the very best of these technological discoveries to doctors and their patients, we must continue to invest in a new era of medicine.
This investment involves supporting scientists in their work to develop evidence-based therapies that provide better treatment outcomes and assisting health professionals and doctors in understanding the role that some of these previously prohibited medicines can play in returning patients to health and wellness.
We also need to ensure these medicines are manufactured safely, go through all the relevant approval processes, and appropriately commercialise these therapies to provide better access and affordability for doctors and their patients.
Medicinal cannabis alone is projected to be a US$100 billion global opportunity over the next 5-7 years. However, this is just the beginning of the next global health revolution that will change the physical and mental health of millions of patients around the world.
As an integrated cannabis and novel medicines manufacturer and distributor committed to improving health globally, we will continue to draw upon the distinctive capabilities of our global executive and leadership team to ensure that these unique medicines gain widespread acceptance as breakthrough therapies.
Our continued work with renowned medical experts, clinical research specialists, transformative diagnostic technology companies, along with a globally connected, influential team of people dedicated to advancing this area of medicine, will bring these life-changing medicines to those who need them most.
With the development and approval of psychedelic-assisted therapies already underway, we are on the cusp of something truly exciting.
Nerissa Bentley
The Melbourne Health Writer
[1] Various publicly available market and academic reports and sources from 2020 – 2021 including Prohibition Partners, ASA Monitor, Business Wire. [2] Carhart-Harris RL, Erritzoe D, Haijen E, Kaelen M, Watts R. Psychedelics and connectedness. Psychopharmacology (Berl). 2018 Feb;235(2):547-550. doi: 10.1007/s00213-017-4701-y. Epub 2017 Aug 10. PMID: 28795211 [3] Johnson, MW, Garcia-Romeu, A, & Griffiths, RR 2017, 'Long-term follow-up of psilocybin-facilitated smoking cessation', The American Journal of Drug and Alcohol Abuse, vol. 43, no. 1, pp. 55-60. [4] Bogenschutz, M., Bogenschutz, M. P., Forcehimes, A. A., Pommy, J. A., Wilcox, C. E., Strassman, R. J., & Barbosa, P. R. (n.d). Psilocybin-assisted treatment for alcohol dependence: A proof-of-concept study. Journal of Psychopharmacology, 29(3), 289-299. [5] Morgan, L. MDMA-assisted psychotherapy for people diagnosed with treatment-resistant PTSD: what it is and what it isn’t. Ann Gen Psychiatry 19, 33 (2020). https://doi.org/10.1186/s12991-020-00283-6 [6] ibid. [7] Nochaiwong, S., Ruengorn, C., Thavorn, K.et al. Global prevalence of mental health issues among the general population during the coronavirus disease-2019 pandemic: a systematic review and meta-analysis. Sci Rep 11, 10173 (2021). https://doi.org/10.1038/s41598-021-89700-8 [8] 11 Network Australia, “Australian experts push for psychedelic drugs to treat mental illness”, 5 August 2021, https://www.youtube.com/watch?v=__Js2PsB0Po [9] ibid