FDA panel rejects first MDMA-based PTSD treatment

A panel of advisors for the Food and Drug Administration voted against a therapy based on the psychedelic MDMA for post-traumatic stress disorder. 

The panel found the available evidence does not show that the drug is effective or that its benefits outweigh the risks. They voted 9-2 that MDMA paired with talk therapy is not effective for treating PTSD, and they voted 10-1 that the benefits of MDMA treatment don't outweigh the risks. 

Panelists and FDA staff discussed shortcomings in the clinical research, including uncertainties and gaps in the data, unanswered questions about its potential for abuse and a lack of evidence supporting the psychological approach used in the therapy sessions. 

While the FDA considers the panel's advice, it is not required to follow the recommendation. 

Read more: NPR 

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