LEGAL PITCH

MDMA-ASSISTED THERAPY FOR THE TREATMENT OF PTSD

On August 9 2024, Lykos Therapeutics announced that the US Food and Drug Administration (FDA) have requested an additional –a third– Phase 3 trial to further study the safety and efficacy of midomafetamine (MDMA) for the treatment of post-traumatic stress disorder (PTSD).

PSBE deeply regrets this decision which will impact millions of patients, in the US and abroad, who are forced to struggle with PTSD and for whom the current treatments do not provide relief.

Standing by the highest standards in mental healthcare, PSBE stresses that psychedelic therapy requires a novel scientific and regulatory approach. Such approach needs to recognize that current placebo-control and blinding procedures are by definition inoperable with psychoactive substances, and hence, like is the case for surgical procedures, the need to put in place alternative methods to measure the effectiveness of psychedelic medicines. These implementations need to consider that the mode of action of psychedelic therapy does not solely rely on neuropharmacology but on a combination with psychotherapy. 

PSBE calls for increased public support for research in psychedelic therapy, as novel treatments are urgent to tackle the current mental health crisis.

Psychedelic-assisted therapy: What is it, why is it necessary and how to regulate it?

This document proposes the regulation of Psychedelic-Assisted Therapy (“PAT”). It explains:

  • why this is both necessary and positive
  • it sets out the challenges it would help to address
  • it highlights the significant benefits this would bring to Belgian society.

It also briefly sketches how such regulation can be implemented, and answers some questions this may raise.

DUTCH PITCH
ENGLISH PITCH
FRENCH PITCH