FDA Rejects MDMA Therapy over Protocol Concerns


“In 2016, MAPS and the FDA agreed on a protocol in which an independent assessor who had not taken part in the trial would evaluate each person’s psychiatric progress. But both FDA staff and the advisory committee remained worried that people’s expectations of receiving a drug would affect their response to it.”

“Lykos’s protocol gives therapists substantial discretion in how they treat their clients, which left some committee members concerned that trial participants might have received different therapy experiences depending on whether they received a drug or placebo.”

Cc @Toby