MDMA in Psychiatry – Challenges and Possibilities Ahead

MDMA-assisted therapy was on the brink of FDA approval in 2024. Then came an unexpected setback: the FDA rejected the application. The decision sent ripples through the global psychedelic field, raising urgent questions for clinicians, researchers, and policymakers.

Is another Phase 3 trial necessary? What were the central concerns behind the FDA's decision? How should the field respond strategically, ethically, and clinically?

In this timely conversation, psychiatrist and author Julie Holland joins clinical psychologist Filip Bromberg to explore the implications of this turning point for MDMA-assisted therapy and the future of psychedelic medicine.

Dr. Holland is a psychiatrist specializing in psychopharmacology and a long-standing voice in psychedelic research and advocacy. She previously worked for nearly a decade at Bellevue Hospital's psychiatric emergency room and serves as a medical advisor to MAPS.

In this webinar, we explore:

• The FDA rejection of MDMA-assisted therapy and its clinical implications
• Whether an additional Phase 3 trial is needed
• Methodological and ethical critiques of existing MDMA trials
• Harm reduction and patient safety in psychedelic treatment
• The relational and therapeutic elements essential for effective MDMA therapy
• Strategic pathways forward for the global psychedelic field

Please note: Due to technical connection issues during the live event, only the audio recording of Julie Holland is included in this video.

This webinar is presented by Borealis Psychedelic Science Summit in collaboration with Lavin.