The conversation on psychedelics around the world continues to evolve, with more and more emerging clinical data highlighting their potential to treat mental health disorders. Last year’s developments – see our previous blog post here – led us to anticipate an upcoming change but yet the legal landscape remains unchanged.
In the UK, the independent Parliamentary Office of Science and Technology (POST), which is one of the first independent bodies of its kind in the world that sources independent analysis of public policy issues relating to science and tech for government, has issued another rapid response on psychedelic-assisted therapy for post traumatic stress disorder (PTSD). POST in the past has also published briefings focussed on the use of psychedelics to treat depressive disorders, anxiety disorders and eating disorders. The response is intended to inform policymakers on the topic as increasing research around psychedelics shows the compounds may hold promise as innovative treatments in the area of mental health. These POST responses will be followed by a POST note that will summarise the headline research findings and outline the main policy issues, including how the national legislative framework on controlled drugs impacts researchers’ ability to carry out studies, with reference to international legislative approaches. It will also explore public attitudes to using these drugs therapeutically. Despite the increased activity in this area, and the push of advocacy groups for a change in legislation, the current government had not progressed any proposals to review or change the status of psychedelics and we now await the approach of a new government to be formed on 5 July.
In the EU, the European Medicines Agency (EMA) held its planned multi-stakeholder workshop on psychedelics last month, contemplating an EU regulatory framework, covering clinical trial design, setting research potential implications for future approval, challenges with health technology assessment post approval, and considering the Australian and American perspectives. That the event was held indicates a willingness and openness to discuss the EMA’s current approach to regulating these drugs and a willingness to issue further the regulatory challenges associated with the development and evaluation of psychedelics and to issue further regulatory guidance where required. Despite an increased level of interest in this area, there are no announcements or proposals for a change in legislation at an EU level as of yet.
The US continues to be the most proactive and innovative market in this area. Almost a year after the issuance of its guidance on “Psychedelic Drugs: Considerations for Clinical Investigations” in June 2023, FDA granted breakthrough therapy designation to an LSD-based treatment for Generalized Anxiety Disorder (GAD). The drug, a form of LSD (lysergide d-tartrate) designated as MM120, is being developed by biopharma company MindMed as a treatment for GAD, a condition characterized by persistent and severe worry about aspects of day-to-day life. However, on June 4, an FDA Psychopharmacologic Drugs Advisory Committee (PDAC) concluded the clinical trial data provided by Lykos Therapeutics were not enough to show that MDMA-assisted psychotherapy was effective and safe to treat PTSD. FDA advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. The FDA’s approval decision is expected by the Prescription Drug User Fee Act (PDUFA), with a target action date of August 11, 2024.
Regulators thus continue to move at different paces in the various markets. However, what is yet to be seen is a more holistic scientific and regulatory framework for psychedelic research and treatment approval.
We continue to monitor this space and will report on future updates.
For further information, please contact Xin Tao, Julia Gillert or Elina Angeloudi.
