FDA Expert Committee to Assess MDMA-Assisted Therapy for PTSD in Upcoming Review

The Food and Drug Administration (FDA) is poised to embark on a significant milestone in the field of psychedelic medicine as it prepares to review MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD). Here’s a breakdown of the upcoming expert committee meeting:

Historic Review:
The FDA’s Psychopharmacologic Drugs Advisory Committee will convene on June 4 to scrutinize the evidence behind the application for MDMA-assisted therapy, marking the first time in 25 years that the FDA has evaluated a new PTSD treatment. This milestone also represents the first instance in history where the agency has considered a new drug application for a psychedelic substance.

Lykos Therapeutics Announcement:
Lykos Therapeutics (formerly MAPS Public Benefit Corporation) revealed the scheduling of the FDA committee meeting on Monday. CEO Amy Emerson hailed it as a “significant milestone,” reflecting decades of clinical research and advocacy in the field of psychedelic medicine.

Clinical Trial Data:
The expert panel will review a comprehensive data package, including findings from two randomized, double-blind, placebo-controlled Phase 3 studies assessing the safety and efficacy of MDMA-assisted therapy.

Priority Status:
FDA granted the MDMA new drug application a priority status, fast-tracking the review process. If approved, MDMA would be administered in conjunction with psychological intervention as a prescription treatment for adults with PTSD.

Regulatory Implications:
Approval of the MDMA new drug application would necessitate rescheduling by the Drug Enforcement Administration (DEA). This would mark a historic moment as MDMA becomes the first psychedelic substance approved as a pharmaceutical for therapeutic use.

Breakthrough Designation:
FDA designated MDMA as a “breakthrough therapy” in 2017, recognizing its potential based on previous trials sponsored by MAPS. The NDA submitted to FDA draws upon findings from 18 Phase 2 and Phase 3 trials.

Evolving Standards and Research:
Recent developments include FDA’s issuance of draft guidance on studying psychedelics and the implementation of psychedelics-specific codes by the American Medical Association. Research findings continue to underscore the potential of psychedelics in mental health treatment.

Government and Legislative Interest:
The Biden administration has expressed interest in exploring the therapeutic potential of psychedelics, while bipartisan lawmakers have advocated for VA’s provision of MDMA-assisted therapy for veterans upon FDA approval.

Policy Shifts:
Proposed changes to federal workforce drug testing guidelines signal a shift away from MDMA screening and towards addressing substances like fentanyl.

The upcoming FDA committee review represents a pivotal moment in the trajectory of psychedelic medicine. As stakeholders await the outcome, the potential approval of MDMA-assisted therapy for PTSD holds promise for transforming mental health treatment paradigms.