Exclusive: Therapists and Trialists from Lykos’ Phase 3 MDMA-Assisted Therapy Studies Push Back on ICER’s Critical Draft Report

MDMA-assisted therapy for PTSD gets rebuttal from therapists and trial contributors who worked on Lykos Therapeutics' Phase 3 studies in response to ICER's March 26, 2024 draft evidence report. They argue that parts of ICER's critique misrepresent the Phase 3 trials, focusing particularly on the validity of the primary outcome measure (CAPS-5), the likelihood and impact of functional unblinding, and how psychotherapy is standardized and monitored across sites. The group also contends that expectancy effects and adverse event reporting were managed through structured therapist training, supervision, adherence ratings, and emphasis on accurate documentation. They further address ethical concerns, distinguishing potential malpractice or boundary violations from treatment-emergent adverse events, while still calling for rigorous therapist training and accountability. They conclude that the Phase 3 efficacy and safety data support a favorable benefit-risk ratio and want ICER's final report to more accurately reflect the evidence behind MDMA-AP for PTSD.