FDA Panel Votes Against First Proposed MDMA-Based Drug

Available data did not show a benefit to the PTSD patients for which it was intended.

This week, a Food and Drug Administration (FDA) advisory panel voted against a psychedelic therapy for post-traumatic stress disorder (PTSD). The panel said that available clinical data on the MDMA-based drug did not show effectiveness in PTSD patients.

This was the first time an MDMA-based drug was formally considered by the FDA. The panel was not opposed to the concept of the drug, which was formulated by Lykos Therapeutics to treat PTSD, but took issue with the poor design of the clinical trials that led to inadequate data collection.

“It seems like there are so many problems with the data – each one alone might be okay, but when you pile them on top of each other, there’s just a lot of questions still I would have about how effective the treatment is,” said Melissa Barone, a panel member who voted against the treatment.

As the Lord Leads, Pray with Us…

  • For Commissioner Robert Califf and FDA researchers as they provide oversight and review for the treatments, therapies, and medications made available to the American public.
  • For wisdom for Secretary Xavier Becerra as he oversees the many agencies within the Department of Health and Human Services.

Sources: Reuters, Military Times


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