FDA Rejection Of MDMA Could Fuel Black Market Demand, Warns CEO Of Women’s Psychedelic Platform SetSet
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.