FDA Rejects MDMA-Assisted Therapy For PTSD

The FDA has rejected a first-of-its-kind proposal to use the psychedelic drug MDMA as a treatment for post-traumatic stress disorder (PTSD), according to drugmaker Lykos Therapeutics. NBC News reports: There had been intense political pressure on the FDA to approve the drug. Friday's decision was the first time the agency had considered a Schedule 1 psychedelic for medical use. If approved, it would have been the first new treatment for PTSD in more than two decades. Lykos Therapeutics had asked the FDA to approve the drug as part of a treatment regimen, given alongside talk therapy. The agency's decision came after an independent advisory committee in June declined to recommend approval of the drug, saying there was not enough evidence that the therapy was safe and effective. 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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