What to Expect: FDA Advisory Committee Set to Review MDMA-Assisted Therapy for PTSD

Next week, the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) will meet to discuss Lykos Therapeutics’ MDMA-assisted therapy for PTSD New Drug Application (NDA).

While PDAC’s determination on whether the therapy should be approved is non-binding, the meeting—which is scheduled to run between 8:30 AM and 4:30 PM EST on June 4th—provides an opportunity for a first look at how the FDA might appraise the first psychedelic-assisted therapy to land on its desk.

Given that this might be the first FDA advisory committee meeting to attract such levels of interest, this short Preview article aims to get you oriented re: what to expect. We cover: the role and function of advisory committees; PDAC’s membership; background materials and potential voting questions to expect; and, an anticipated order of play for the day itself.