Last month, psychedelic drug developer MindMed scored an FDA breakthrough therapy designation for its LSD-D-tartrate candidate (MM120) in the treatment of generalised anxiety disorder (GAD). The company is preparing to launch a Phase 3 program by year-end. (See FDA Hands MindMed’s LSD Candidate Breakthrough Therapy Designation in Generalised Anxiety Disorder….)
Notably, MindMed and its executives are keen to emphasise the absence of ‘psychotherapy’ from its protocol, repeatedly stating that there was ‘no psychotherapeutic intervention’ in the Phase 2b study.
As I explore here, however, debates around what constitutes ‘psychotherapy’ and ‘psychotherapeutic intervention’ are increasingly salient among psychedelic researchers, practitioners and drug developers. These debates are exacerbated by a lack of a common—or at least consensus—language or delineation of these terms.
There’s also the matter of different audiences: while researchers and practitioners might be appealing to their colleagues, drug developers are often looking to couch their protocols in a way that’s familiar or attractive to regulators and investors: both of whom might prefer an approach, or communiqué, that emphasises drug effect.
Here, I (Josh Hardman) speak with people close to the study itself as well as MindMed representatives including CEO Robert Barrow to look at the (unpublished) protocol employed in the Phase 2b study. Beyond this particular study, I touch on some of the broader debates around psychotherapy in psychedelic treatment protocols, MindMed’s regulator-friendly rhetoric and commercial positioning, as well as what these treatments might look like in a post-approval world.
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