The U.S. Food and Drug Administration (FDA) dealt a major blow this week to supporters of psychedelic-assisted therapy, rejecting MDMA as an approved treatment for post-traumatic stress disorder (PTSD). Another remarkable announcement, one with profound implications for the future of psychiatric care through psychedelics, was made on August 9, 2024.
The Blow of Turned-Down Offers
The FDA then told the company developing MDMA therapy, Lykos Therapeutics, that they “had not demonstrated that [their] drug is safe and effective.” The regulatory body requested an extra-late-stage study, a step that usually takes several more years and huge money.
The rejection is a disappointment to many who had hoped MDMA would be the first illegal psychedelic to win FDA approval as a medicine. If MDMA suffers, so might the entire emerging field of psychedelic-assisted therapy.
FDA Determinants For this Sentence
1. Limitations of the study: In their application, the FDA decided there were “substantial limitations” that prohibited them from determining whether MDMA is safe and effective in treating PTSD.
2. Blinding issues: Reviewers at the FDA observed that, in most cases, patients were able to correctly guess whether they had been getting MDMA or placebo from their side effects of Lykos’ trials, which was a problem as it compromised study tip-offs.
3. Claims of Impropriety: There were reports that some researchers might have been coaching patients to minimize negative results or enhance positive ones.
4. Safety: An FDA panel raised concerns in a June meeting about potential harms like heart problems, injury, and abuse.
Impact on PTSD Treatment
This will be an unfortunate decision for many patients who are looking to have more options for treating PTSD. The only FDA-approved drugs for PTSD, which has depression and anxiety at its core as well as suicidal ideation, are currently antidepressants. Between the re-experiencing of memories and poor quality of life, PTSD presents itself as not just a psychological problem but also one in need of developing new treatments.
A Call for Psychedelic Healing
1. Legislative support: More than 80 House and Senate lawmakers recently signed off on letters encouraging the FDA to approve MDMA for PTSD.
2. Veteran advocacy: When it comes to veteran advocacy, combat veterans have been some of the most vocal proponents, saying that they believe cannabis could help address high suicide rates among military service members.
3. Ongoing research: Research is ongoing with other psychedelics, such as psilocybin for depression and anxiety.
FDA’s denial of MDMA has dealt a major blow
1. Additional innovation: The FDA said it will further support “innovation for psychedelic treatments and other therapies to address these medical needs.”
2. Ongoing studies: Companies like Compass Pathways and Usona Institute are conducting late-stage studies of psilocybin for severe depression.
3. Better clinical trials: The renewed examination of the MDMA studies could ultimately result in more rigorous research from now on.
What’s Next for MDMA Therapy?
Lykos Therapeutics plans to request that the FDA reconsider its decision. Still, another large-scale study would almost certainly set back approval by years. Their experience is a setback for the development of psychedelic medical treatments, despite mounting interest and some promising early data.
Conclusion
However, the FDA shutting down their approval of MDMA for PTSD therapy constitutes a pivotal moment in psychedelic medicine. This is naturally disappointing for everyone involved—people living with epilepsy more than most—but it also illustrates how high the bar has to be raised when it comes to drug approvals, especially around drugs that have a complicated history. The future of psychedelic-assisted therapy is still debated by some in the high echelons of mental health, and clinical work will evolve as research continues.