Reported 6 months ago
An expert panel advising the FDA voted against recommending approval of MDMA as a psychotherapeutic catalyst due to concerns about its safety and effectiveness in treating PTSD. The panel questioned the unblinding of subjects in studies, potential underreporting of adverse events, and inadequate assessment of MDMA's abuse potential, despite positive results showing significant reductions in CAPS-5 scores. The FDA's advisers also raised worries about the lack of blinding, underreported negative effects, and an incident of sexual misconduct involving therapists. The decision poses a setback for efforts to introduce MDMA-assisted therapy, despite recognition as a 'breakthrough therapy' with potential benefits for PTSD patients.
Source: YAHOO