In 2018, countries around the world saw a dramatic change in attitudes towards medical cannabis. In the US, 33 states and the federal district of Washington, DC legalised the use of medical cannabis, and across the pond, the UK Government moved many cannabis products from Schedule 1 drugs to Schedule 2, allowing them to be prescribed by specialists to those who might benefit from its therapeutic potential in childhood epilepsy, amongst others.
This medical cannabis breakthrough was followed in early 2019 by the approval of esketamine nasal spray for supervised administration to adults suffering with treatment-resistant depression. This breakthrough marked the first major advance in the treatment of depression since the late 1980s.
In this context of more open-mindedness towards once stigmatised illegal and recreational drugs as medicines, another Schedule 1 drug, ‘mind manifesting’ psychedelics, such as psilocybin from magic mushrooms, LSD and mescaline, are also beginning to be greeted with optimism by the clinical community, regulators and investors.
These positive attitudes are due to how, like ketamine, psychedelics have the potential to be a game-changing treatment in mental health. Not only have mental health disorders proven incredibly challenging to treat, but the incidence and impact of these conditions is only growing; the world is undoubtedly living in an escalating mental health crisis.
To find out if their promise can become a reality, a healthy competitive landscape of pharma companies have begun working on developing and trialling psychedelic drugs, including Champignon Brands, ATAI Life Sciences, Field Trip Psychedelics and Eleusis.
Explaining the current renaissance
Despite being used as medicines for thousands of years, psychedelics didn’t become commonplace in mainstream Western culture until the 1940s and 1950s. Initially this was focused in academic settings, but over time “psychedelics moved out of these settings into the hippie movement and counterculture,” explains Field Trip Psychedelics founder and executive chairman Ronan Levy. This prompted political backlash and their designation as Schedule 1 products in the 1960s and 1970s.
This made research incredibly challenging, but non-profit organisations such as the nary Association for Psychedelic Studies (MAPS) and the Beckley Foundation were undeterred. Over the next three decades or so, scientists “amassed data that suggested there was something quite intriguing about psychedelics from a mental health perspective,” notes ATAI chief scientific officer Srinivas Rao.
Due to the hard, clinically rigorous work of the non-profits and academic researchers, including Roland Griffiths at John Hopkins University and David Nutt at Imperial College London, by the 2000s and 2010s psychedelics had begun to experience a resurgence.
Data showing psychedelics’ promise in mental health caught the eye of the FDA, leading the regulator to declare the psychedelic psilocybin as a possible breakthrough drug and giving it “unmatched credibility,” explains Champignon CEO Dr Roger McIntyre. To date, two psilocybin-based drugs have received FDA breakthrough designation – ATAI’s investment portfolio company COMPASS Pathways for treatment-resistant depression and the Usona Institute’s for major depressive disorder. The European Medicines Agency has taken a similar approach to psychedelics in the past few years.