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 BROCHURE: What is it, why is it necessary and how to regulate it?

Our brochure is an informative document that proposes the regulation of Psychedelic-Assisted Therapy (“PAT”). It explains:

  • what are psychedelic substances
  • what are the different therapeutic applications
  • what is the current regulatory state of play

This brochure was edited for our Annual Symposium in November 2024. 

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