Big pharma is about to tune in to the potential of psychedelics – Wired.co.uk

Psychedelic medicine will begin to cross over into the mental health mainstream in 2021. In both Europe and the US, medicines regulators have eased restrictions on using MDMA to treat post-traumatic disorder (PTSD), and on psilocybin the active substance in magic mushrooms to treat depression. 2021 will bring new clinical trials, as support for the use of psychedelics in medicine continues to gain momentum.

Clinical research into psychedelics has boomed in the past five years and investors are taking note. The US Multidisciplinary Association for Psychedelic Studies (MAPS), which researches the topic, reached a $30 million (23 million) fundraising target in 2020, on top of $80m of historical funds. This money will enable the completion of a phase-3 trial in the use of MDMA to treat PTSD, which will be necessary to achieve Food and Drug Administration approval. In the UK, London-based mental-health care company COMPASS Pathways has raised more than $115m to fund its efforts and bring to market a psilocybin treatment for depression. In August, the company filed an application to issue an IPO on the Nasdaq.

One barrier to the use of psychedelics in medicine is government regulation. The 1971 United Nations Convention on Psychotropic Substances placed psychedelics in its most restrictive category, Schedule 1, above drugs such as fentanyl, methamphetamine and cocaine. Legal-access loopholes exist in pockets of Europe and the Americas, but now governments are being increasingly lobbied to revise what many see as out-of-date policies. In November 2020, legal, regulated psilocybin therapy was approved for use in Oregon.

It is important not to underestimate the effect of drugs such as psilocybin. In a study we carried out at Imperial College Londons Centre for Psychedelic Research, which I head, 100 per cent of participants ranked a 25mg psilocybin experience as the single most intense state of consciousness of their lives. Because of this, 2021 will see the arrival of smartphone apps for those who use psychedelics, which will focus on harm reduction, including an app being developed by Imperial called MyDelica.

We are launching this app not only because of concerns about the growth of psychedelic misuse, but also the need to establish guidelines for their safe use, and to help with ongoing research. Without these, psychedelics might no longer show the same safety and efficacy that weve become accustomed to seeing from controlled research, and set back progress.

In 2021, big pharma could also enter the psychedelic space, as we continue to understand the drawbacks of treatments such as selective serotonin reuptake inhibitors (SSRIs). Since they were introduced to the market in 1987, SSRIs have been hugely profitable for pharmaceutical companies, but their efficacy and safety continue to be questioned. In one clinical trial of 59 individuals with a major depressive disorder, which we completed in 2020, we compared 43 daily doses of the SSRI antidepressant escitalopram with just two 25mg doses of psilocybin plus equivalent psychological support for each condition. The results will be published in early 2021.

As patents on many conventional antidepressants begin to expire and public and regulatory opinion regarding psychedelics is changing 2021 will be the time that psychedelic therapy casts a spotlight on the limitations of current mental-health care treatments, and highlights a bold alternative.

Robin Carhart-Harris is head of the Centre for Psychedelic Research at Imperial College, London

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Big pharma is about to tune in to the potential of psychedelics - Wired.co.uk