ACS Pharmacology & Translational Science
August 8, 2025
Kate Browne, Ewa Bałkowiec-iskra, André Elferink et al.
1 citation
Marketing authorization applications for psychedelics must align with the regulatory requirements and evidentiary standards required for the approval of all medicinal products in the European Union. While medicine regulators recognize the therapeutic potential of psychedelics, their characteristics present methodological challenges that complicate the design and interpretation of pivotal trials...
Fundamental and Clinical Pharmacology
July 16, 2025
Makiath Adebo, Marie Laure Bonnet, Ons Laouej et al.
10 citations
ABSTRACT In the 1950s–60s, serotonergic psychedelic drugs were studied as potential adjuvants to psychotherapy to treat addiction and alcoholism. However, starting in the 70s, preclinical and clinical studies on psychedelics stopped for decades because legislation controlled its recreational use, citing their hallucinogenic and psychotomimetic effects, as well as their abuse potential....
European Psychiatry
2025
Marianne Destoop, Pavel Mohr, Florence Butlen-Ducuing et al.
7 citations
Abstract Background Recent years show an exponential increased interest (“renaissance”) in the use of psychedelics for the treatment of mental disorders and broader. Some of these treatments, such as psilocybin for depression, are in the process of formal regulation by regulatory bodies in the US (FDA) and Europe (EMA), and as such on the brink of real-world implementation. In the slipstream of...
Neuroscience applied..
2025
Francisca Silva, Florence Butlen-Ducuing, Lorenzo Guizzaro et al.
4 citations
There is a growing body of clinical research on the therapeutic potential of psychedelics for the treatment of mental health disorders, notably depression. Accordingly, the new revision of the European Medicines Agency guideline on the clinical investigation of products for depression will incorporate a section covering specific regulatory recommendations for the design of studies with...
Neurosci Appl
January 11, 2024
Drummond E-Wen Mcculloch, Matthias E. Liechti, Kim Pc Kuypers et al.
10 citations
Psychedelic drugs including psilocybin and LSD are undergoing clinical trials for a range of psychiatric and neurological conditions, and have particularly shown substantial promise in phase 2 studies of depression. In this article we outline key knowledge gaps that may be imperative for a successful implementation of psychedelic drugs as medicines as identified by members of the European...