2023 is expected to be a pivotal year for psychedelic-assisted therapy, with multiple compounds entering the final stages of drug development. Many of these treatments have been designated as breakthrough therapies by the FDA, with the potential to treat serious conditions in underserved patient populations.
The Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medical treatments in the UK, has awarded Innovation Passports to psychedelic-assisted therapies to accelerate their time to market through the Innovative Licensing and Access Pathway (ILAP).
In conversation with PSYCH for The Psychedelics as Medicine Report, Dr Laura Squire, Chief Healthcare Quality and Access Officer at MHRA, said ‘The ILAP combines the MHRA’s globally recognised high standards of quality and safety with improved flexibility to reduce the time it takes innovative treatments to be available to NHS patients. The “Innovation Passport”, a new medicine designation, acts as the gateway to entry into this pathway and is awarded to innovative products submitted to the ILAP.
‘This is an age of change, and we see ourselves as a collaborative and enabling regulator that looks for opportunities to support innovative new products and ways of working. We aim to combine a high level of scientific support and expertise with agility, to enable robust decisions to be reached in the shortest possible time.’
The MHRA has granted Innovation Passports to MAPS for its MDMA-assisted therapy for PTSD, COMPASS Pathways for COMP360 psilocybin therapy for treatment-resistant depression, and to Small Pharma for SPL026, its DMT formulation to treat patients suffering from Major Depressive Disorder.
‘The first thing you get is the passport, but actually it’s a whole series of meetings with the MHRA, NICE and the NHS,’ explained Dr Carol Routledge, Chief Medical and Scientific Officer at Small Pharma. ‘As you develop your molecule through to the market, you get the input of all these partners. So not only is it a fast track, but they also really help in terms of your development plan and how you take your molecule forward. For us, it’s going to be really important, and I am really pleased we are part of that process.’
The MHRA is not the only UK government agency to show significant support for the development of psychedelic medicines, with the National Institute for Health and Care Research and the Medical Research Council committing some £1.5 million to Awakn’s Phase III trial with ketamine-assisted therapy in the treatment of alcohol use disorder.
Commenting on the study, which will take place across seven NHS sites, Awakn’s head of ketamine-assisted psychotherapy for addiction, Professor Celia Morgan, said: ‘The NHS incurs high costs from people not recovering from alcohol use disorder, about £3.5 billion a year, so any effective treatment represents a substantial cost saving. It’s huge that the NHS has identified the need and wants to be involved from the outset, which is excellent, and we’re really enthusiastic to partner with them.’
As clinical trials demonstrate the efficacy of psychedelic-assisted therapies to treat serious psychiatric conditions and transform patient outcomes, public pressure is mounting on the government to enact regulatory reform that facilitates further research and cements the UK as an epicentre for psychedelic healthcare.
In the House of Commons, Crispin Blunt MP, Chair of The Conservative Drug Policy Reform Group, called on the prime minister to remove barriers to research with psilocybin. Blunt, who recently joined Psych Capital’s Medical Psychedelic Technical Advisory Board, told PSYCH: ‘There is a consensus that the research should be enabled and that the evidence should be able to be collected – and that’s essentially across the board.
‘It’s actually trying to find opposition, and why would anyone oppose rescheduling? There is no credible public policy argument to leaving these things in schedule one. The number of my colleagues who actually stand in the way of this is less than ten, out of 651 in the House of Commons.’
Shaping the future of psychedelic healthcare
As the number of clinical trials with psychedelic medicines in the UK grows, and research reaches a tipping point, PSYCH Symposium returns to London on Thursday, 6 July, to expedite the adoption of psychedelic healthcare.
Europe’s leading psychedelic medicine conference provides a stage for the industry’s most influential figures to connect and collaborate. Speaking on the importance of PSYCH’s annual symposium, Dr Routledge commented: ‘It’s about education. In many European countries, psychedelic-assisted therapy is quite new, so we have to bring the regulators along with us. I think holding these conversations is really important, to inform various policies in different countries.’
The UK is home to world-leading psychedelic research institutions and publicly traded companies, with direct access to London’s capital markets. This lays solid foundations for a domestic industry, with the PSYCH Symposium championing the emerging ecosystem.
PSYCH Symposium: London 2023 provides a platform for decision makers to accelerate the development and delivery of psychedelic medicine. Secure your Early Bird ticket today at a discounted price of £299: https://www.psychsymposium.com/