The Food and Drug Administration (FDA) advisory panel has dealt a significant blow to the growing field of psychedelic medicine by rejecting MDMA-assisted therapy for post-traumatic stress disorder (PTSD). The decision, made in early August, stemmed from concerns about the design of clinical trials, the potential for MDMA abuse, and uncertainty surrounding the role of accompanying psychotherapy. The panel also cited allegations of misconduct during the Lykos Therapeutics study.
For advocates of psychedelic medicine, this rejection represents a major setback. April Pride, CEO and founder of SetSet, a company dedicated to harm reduction in the psychedelic space, expressed her disappointment: “The FDA’s decision is a significant setback for the psychedelic medicine community.” She fears that the rejection could drive demand for unregulated and potentially unsafe MDMA products on the black market as individuals and practitioners seek alternative treatment options.
SetSet, recognizing the growing use of psychedelics outside of clinical settings, is actively working to address safety concerns. The company provides harm-reduction education, particularly for its female members, who are more likely to encounter challenging experiences due to hormonal fluctuations. They offer information on testing kits, dosage instructions, and therapeutic support, aiming to mitigate the risks associated with psychedelic use.
Pride advocates for regulatory reform, arguing that a specialized pathway for psychedelics is crucial to balance innovation with patient safety. This pathway would allow for ongoing approval processes, enabling the collection of real-world evidence while ensuring patient protection. She also emphasizes the need for robust education and certification programs for practitioners, alongside stricter guidelines for third-party testing to combat adulterated products.
Despite the FDA’s rejection, Pride remains optimistic about the future of psychedelic medicine. She believes that the setback will drive innovation within the industry, with increased focus on compounds like psilocybin and ketamine, which have shown promising safety profiles. She also anticipates efforts to improve drug formulations and safety protocols to address the FDA’s concerns.
The FDA’s decision has sparked a critical conversation surrounding the future of psychedelic therapy. While the road ahead may be challenging, advocates like Pride remain committed to promoting responsible and safe access to these transformative treatments for those in need.
