A Food and Drug Administration (FDA) advisory panel overwhelmingly rejected MDMA-assisted therapy for treating post-traumatic stress disorder (PTSD). in early August, citing significant concerns about the treatment and research process.
Among the primary issues were design flaws in clinical trials, the potential for MDMA abuse and uncertainties surrounding the role of accompanying psychotherapy. The panel also pointed to allegations of misconduct during the Lykos Therapeutics study.
See Also: FDA Rejects MDMA For PTSD Treatment, Calls For More Research On Psychedelic Therapy
For advocates of psychedelic medicine, this rejection is a major setback. April Pride, CEO and founder of SetSet, is among them. “The FDA’s decision to reject the new drug application for MDMA to treat PTSD is a significant setback for the psychedelic medicine community,” she told Benzinga in an exclusive interview.
“This rejection might inadvertently drive the demand for unregulated, unsafe MDMA products on the black market as patients and practitioners seek alternative means of treatment,” Pride added.
Prioritizing Safety: How SetSet Is Driving Progress In Psychedelic Harm Reduction
Pride’s company, SetSet, is addressing these safety concerns head-on. Focused on providing harm-reduction education, SetSet ensures that its female members, many of whom use psychedelics outside clinical settings, have access to safe practices.
“We know that three out of four people take psychedelics outside of a clinical setting, so to ensure safe practices, we provide harm-reduction education created by licensed healthcare practitioners,” she said.
SetSet also offers transparency on testing kits, dosage instructions and therapeutic support – all aimed at reducing the risks associated with psychedelic use.
Pride noted that “one in five people have challenging experiences, and intentional, therapeutic support can help unwind thoughts and feelings.”
She also pointed out that there’s a higher likelihood of difficult psychedelic experiences among women, which can be linked to hormonal fluctuations. “Female hormones are likely the reason that women are more likely to have difficult experiences, so SetSet also educates them about the optimal timing of administration to align with menstruation.”
Urgent Call For Regulatory Reform In Psychedelic Therapy
In response to the FDA’s ruling, Pride advocates for regulatory reforms, insisting that a “specialized regulatory pathway for psychedelics” is necessary, one that allows for an ongoing approval processes.
“This would enable real-world evidence collection while ensuring patient safety rather than requiring absolute certainty before approval,” she explains. Pride also stressed the importance of education and certification programs for practitioners and stricter guidelines for third-party testing to protect consumers from adulterated products.
The Future Of Psychedelic Medicine
Despite the FDA’s decision, Pride says she remains optimistic about the future of psychedelic medicine. While the FDA’s rejection might slow down the industry’s momentum, Pride believes it will spur innovation. “We may see an increased focus on other promising compounds, such as psilocybin and ketamine, which have shown firm safety profiles in clinical trials,” she said.
Pride also foresees efforts to improve drug formulations and safety protocols to address the FDA’s concerns. “For example, one lab is working on an MDMA-like compound that mitigates the challenges of MDMA down-regulation, which speaks to the FDA’s concern with neurotoxicity.”
In the long run, this setback could lead to a more resilient and well-regulated industry. As Pride explains, the industry’s ability to adapt and address these challenges will be key to usher in “transformative treatments to those in need.”
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