Analysis: FDA Advisory Committee Snubs MDMA-Assisted Therapy for PTSD in Overwhelming “No” Vote

Last Tuesday, the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) met to discuss Lykos Therapeutics’ MDMA-assisted therapy for PTSD New Drug Application (NDA).

The meeting, which at nine hours long was only slightly lengthier than an MDMA administration session, was one of the most closely-watched Advisory Committees (AdComms) to date, with more than a thousand people tuning in to the FDA’s live video stream and thousands more reading our live coverage on the day.

As you will have surely seen, both the tenor and voting outcomes of the meeting were decidedly pessimistic; with the committee voting nearly unanimously that the available data is insufficient to show the intervention is effective in PTSD, and that its benefits do not outweigh its risks (even in the context of the FDA’s proposed risk evaluation and mitigation strategy (REMS)).

Given our extensive live coverage on the day, and the many pieces of mainstream and industry coverage of the meeting in the interim, I won’t rehash the day’s events here nor attempt to provide a blow-by-blow account. I also don’t engage too deeply in matters such as the merits of the FDA’s and AdComm’s critiques of things like functional unblinding—others have done a good job of this.

Instead, now that the dust has begun to settle, I (Josh Hardman) attempt to explore some of the lesser-discussed themes that emerged in the meeting, and aftermath...