FDA Rejects MDMA-Assisted Therapy For PTSD
The committee cited a myriad of concerns, including poorly designed studies, allegations of sexual misconduct during a midstage clinical trial and the potential for serious health risks after taking the drug, including heart problems and abuse. A review by FDA scientists, published ahead of the June meeting, also raised concerns about how the trials were carried out, including that a number of patients and therapists likely were able to guess who was given the medication and who got the placebo. Despite the rejection, experts say they expect that psychedelic therapies are still on their way to FDA approval. There are around four dozen MDMA trials in various stages of clinical development, according to ClinicalTrials.gov. “I think it will be a temporary setback,” said Holly Fernandez Lynch, an associate professor of medical ethics at the University of Pennsylvania. “The advisory committee and FDA gave very clear indications of what they’re looking for in terms of study design and adverse event reporting, so Lykos and other companies should know pretty clearly how to proceed going forward if they want to get psychedelics approved.”
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