Trump administration officials, including RFK Jr., endorse psychedelics following a disappointing FDA decision
In recent developments, the evaluation and potential approval of MDMA (ecstasy) for medical use, especially for the treatment of Post-Traumatic Stress Disorder (PTSD), is showing cautious but increasing momentum. Despite no final approval having been granted yet, experts and advocates remain optimistic.
The FDA's recent rejection of an application by Lykos Therapeutics to offer MDMA-assisted therapy for PTSD indicates that the formal approval process has encountered setbacks. However, this decision has not dampened enthusiasm among those championing for this innovative treatment.
Dr. Mike Davis, the new deputy director of the FDA’s Center for Drug Evaluation and Research (CDER), is leading a renewed focus within the FDA and the U.S. Department of Health and Human Services on streamlining regulatory pathways for psychedelic drug development, including MDMA. Davis' expertise in psychiatry and psychopharmacology aligns with the agency’s expressed goal to prioritize psychedelic therapies for difficult-to-treat conditions such as PTSD.
The Department of Veterans Affairs and other policymakers have shown interest in psychedelic therapies, which may further influence regulatory openness given the large burden of PTSD among military veterans and the calls for responsible exploration of the benefits and risks of these treatments.
Internationally, progress is visible. In Australia, for instance, EMD has achieved Authorised Prescriber Status from the TGA, with clinical data demonstrating significant reductions in PTSD symptoms and secured funding agreements from insurers to deliver MDMA-assisted therapies more broadly.
While the FDA is expected to make decisions on various drug applications throughout 2025, there is no public indication that MDMA-assisted therapy for PTSD is on an imminent FDA Prescription Drug User Fee Act (PDUFA) date or immediate approval timeline like some other new drugs. However, the general expectation is that regulatory review for psychedelic therapies will gain momentum and become more streamlined.
Meanwhile, the National Institute on Drug Abuse (NIDA) funded preliminary studies on using ibogaine as an addiction treatment three decades ago but discontinued the research due to cardiovascular toxicity. However, the state of Texas has approved a $50 million research grant for studying ibogaine, a potent psychedelic, as a treatment for opioid addiction, PTSD, and other conditions.
Marcus Capone, a Navy Seal veteran, described his first ibogaine session as a "complete purge of everything," followed by a significant improvement in his mental health. The support for the ibogaine research grant came from Texas' former GOP governor, Rick Perry, and combat veterans.
Despite the promising developments, there is excitement and concern in the field about the drugs potentially being discredited due to their association with controversial views. As these groundbreaking treatments move closer to potential approval, the balance between the promise they hold and the need for careful, objective evaluation remains crucial.
- The advocacy for MDMA, a potential treatment for PTSD, continues to thrive, despite the recent rejection by the FDA of an application by Lykos Therapeutics.
- Beyond MDMA, innovative treatments like ibogaine are also under investigation, as seen in the $50 million research grant approved by the state of Texas to study ibogaine as a treatment for opioid addiction, PTSD, and other conditions.
