FDA Panel Rejects MDMA for PTSD Treatment Citing Flawed Trials

The advisory committee's decision highlights significant concerns over data integrity, study design, and potential misconduct.

Overview

The panel voted 10-1 against recommending MDMA, questioning the validity of the clinical trials.
Key issues included missing data, unblinding of trials, and lack of patient diversity.
Allegations of therapist misconduct and potential abuse of patients were raised during the review.
MDMA's approval would have marked the first new PTSD treatment in over 20 years.
The FDA will make its final decision by August 11, though it often follows the panel's recommendations.