The U.S. Food and Drug Administration (FDA) plays a pivotal role in ensuring that new pharmaceuticals are both safe and effective for public use. This responsibility is especially crucial as innovative treatments emerge to address complex health issues. One example is the approval of psychedelic therapy to treat certain mental health conditions, including Post Traumatic Stress Disorder (PTSD).

Examples of Psychedelics
Therapeutic psychedelics include MDMA and psilocybin. MDMA is a synthetic drug with stimulant and mild psychedelic effect. Psilocybin is a naturally occurring psychedelic compound found in certain types of mushrooms.
Psychedelics in Modern Medicine
In recent years, psychedelics have garnered attention for their potential in treating mental health conditions. The substances are being studied for their efficacy in treating disorders such as PTSD and depression. In 2017, the FDA recognized the promise of these substances by granting “breakthrough therapy” status to MDMA-assisted therapy. This designation facilitates expedited development and review processes for drugs that show substantial improvement over existing treatments.
Since then, initial studies and clinical trials have shown promising results in using MDMA and psilocybin to treat depression, especially in individuals who have not responded well to other treatments. For example, a Phase 2 clinical trial by the Multidisciplinary Association for Psychedelic Studies showed that 58% of participants with treatment-resistant depression no longer met the criteria for depression after receiving MDMA-assisted psychotherapy.
The Setback: FDA Rejects MDMA for PTSD
Despite the initial optimism, the FDA recently rejected an application for MDMA-assisted therapy for PTSD. The agency cited significant limitations in the data provided by the company seeking approval, Lykos Therapeutics. Concerns included issues with trial blinding, potential bias, and the need for additional studies to confirm the drug’s safety and efficacy. Unfortunately, the FDA maintains its position that because MDMA and psilocybin are Schedule I drugs, they have a high potential for abuse. Further, they have no currently accepted medical use.
The Importance of Regulatory Oversight
The FDA’s stringent approval process ensures that new therapies meet high standards of safety and efficacy. This oversight is vital in maintaining public trust and ensuring that innovative treatments do not pose unforeseen risks. Researchers continue to investigate Psychedelic Therapies for treating certain mental disorders including PTSD, depression, anxiety, eating disorders, and substance use.