Interventions of Interest

  • MDMA-assisted therapy

Independent appraisal committee voted that current evidence is not adequate to demonstrate superior net health benefits for MDMA-AP compared to short-term trauma-focused psychotherapies.

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Final Documents

ICER’s Chief Medical Officer, David Rind, MD stated:

“PTSD can be a severe condition affecting nearly all aspects of an individual’s life, and many current therapeutic options are insufficient for many people with PTSD. Despite two randomized trials of MDMA-AP, functional unblinding in the trials and additional concerns around trial design and conduct led to ICER concluding that the publicly available evidence is insufficient to assess the balance of benefits and harms. It was encouraging to learn that FDA is investigating such issues, including those brought to light at our Public Meeting.”