Despite a challenging economic climate in the latter half of 2022, the year was marked by major milestones in psychedelic medicine.
Research is a cumulative process, with subsequent studies building on the success of previous work. This year that research also instigated regulatory reform, following clinical trials which demonstrated the safety and efficacy of psychedelic-assisted therapy.
Below are six significant inflection points in psychedelic healthcare from 2022, set to accelerate the adoption of psychedelic healthcare in 2023.
1. Yesterday, Awakn Life Sciences announced that its Phase III trial to treat alcohol-use disorder with ketamine-assisted psychotherapy will be two-thirds funded by the UK government.
Taking place across seven NHS sites the study is forecast to cost £2.25 million, with the government investing nearly £1.5 million. More than two million UK adults have serious alcohol problems, with alcohol-related harm costing the public healthcare provider around £3.5 billion a year.
Speaking with PSYCH, Dr Ben Sessa, Head of Psychedelic Medicine at Awakn, commented: ‘We have just received approval of a grant from the UK government to cover 66% of the costs of the Phase III trial, which is a fascinating development.
‘We will also be delivering the trial within the NHS infrastructure, which really shows the NHS’s intent to try and adopt the treatment. The reason they are both such great supporters of the research is because of its efficacy.
‘Study participants went from being sober on average seven days a year to being sober on average 314 days a year. That is approximately a three-and-a-half-times greater success rate than the standard care, which is incredible.’
2. Last month, MAPS announced the completion of its second Phase III trial with MDMA-assisted therapy in the treatment of PTSD.
The results of the first half of MAPS’ study were successful, with 67% of participants no longer exhibiting symptoms of PTSD following the study. This is compared with 32% in the therapy-only group. Those in the study also reported lower instances of eating disorders, alcohol use and substance use.
Following the treatment’s expected market approval in 2024, The Psychedelics as Medicine Report: Fourth Edition revealed MDMA-assisted therapy could generate over US$1 billion by 2026.
3. On 8 November, over one million people in Colorado voted in favour of Proposition 122, to decriminalise entheogens and lay the groundwork for the regulation of psilocybin services.
The Natural Medicine Health Act requires rules to be written for a psilocybin programme by 2024, with service centres expected to open in 2025. Counties and municipalities in Colorado can only limit service locations through zoning restrictions, whereas in Oregon 70% of counties opted out of hosting psilocybin services.
As a result, the market in Colorado could quickly become the nation’s biggest. Based on the state’s total addressable market, The Psychedelics as Medicine Report revealed psilocybin services in Colorado generate US$205 million a year.
4. In August, the results were published from a study into the treatment of alcohol use disorder with psilocybin-assisted therapy versus a placebo.
The largest published double-blind study on psychedelics found positive effects on reducing drinking after psilocybin-assisted therapy. Two administrations of psilocybin reduced the number of heavy drinking days from 52% to 10% at the 32-week follow-up.
Almost half of those treated were not drinking at all during the follow-up, versus 25% of those who received only the therapy component.
‘I have no doubt that in the future psychedelic medicine will be available for free on the NHS for a few reasons – it is safe, it’s effective and it is cheap,’ said Sessa.
‘The current treatments for addictions on the NHS are very poor with poor outcomes and are, consequently, very expensive. I’m quite convinced that the NHS will put these medicines into public healthcare because psychedelic-assisted therapies make sense economically.’
5. In May, at the sold-out PSYCH Symposium, MindMed collaborators from University Hospital Basel, Professor Matthias Liechti and Dr Friederike Holze, released topline data from the largest-ever commercial trial with LSD.
In a study of 500 patients with anxiety disorders, 65% saw anxiety levels reduced by over 30%. It has been the first study to show significant lasting effects of a psychedelic medicine, with LSD producing fast and long-lasting reductions in anxiety and depression symptoms up to 16 weeks post-treatment.
Speaking at the event, MindMed’s Chief Executive Officer, Robert Barrow, championed the treatment: ‘One or a few administrations can lead to a rapid and sustained benefit, something we have heard from numerous regulators that they see as a game changer, something that meaningfully shifts how patients are cared for.’
Following the success of the inaugural PSYCH Symposium, the industry-leading conference returns to the iconic British Museum on Thursday, 6 July 2023. Super Early Bird tickets are now on sale for £249 + VAT.
6. At the start of the year, Oregon became the first US state to adopt regulations governing psilocybin services.
In the state’s framework, psilocybin must be administered by licensed facilitators at a licensed facility. As a result, those organisations with psychedelic healthcare clinics, clinicians and therapist training programmes are well positioned to leverage their existing expertise. Organisations that can establish themselves in Oregon, in the nation’s first psilocybin programme, can generate revenue to fund drug development and placate shareholders.
The Psychedelics as Medicine Report projected the total addressable market in Oregon could be worth US$165 million a year. Angela E. Allbee, Oregon Psilocybin Services (OPS) Section Manager at Oregon Health Authority, provided an exclusive contribution for the industry-leading publication.
‘OPS will issue four types of licences,’ said Allbee. ‘Licensed manufacturers to cultivate and process psilocybin products; testing labs to test products; service centres where products can be consumed by clients during administration sessions; and facilitators who will be present to support clients in a non-directive approach throughout the preparation, administration, and integration sessions.
‘All four licence types are really important to the process moving forward in 2023. OPS has tried to expedite rules so that students can be trained and apply for facilitator licences in January, and testing labs can become accredited in time to apply for licences in January.’
For further insights into the psychedelic healthcare industry, download a complimentary copy of The Psychedelics as Medicine Report: Fourth Edition.