Health Affairs August 5, 2024
In June 2024, a Food and Drug Administration (FDA) advisory committee held a hearing to review the evidence for approving a version of midomafetamine (MDMA) therapy, a psychedelic, in combination with psychotherapy to treat post-traumatic stress disorder (PTSD). The committee overwhelmingly voted against approval, concluding that the available data did not show that MDMA is effective in patients with PTSD nor that the benefits of Lykos Therapeutics’ therapy outweighed the risks of treatment, even with some special requirements on clinicians intended to bolster safe prescribing. While the recommendation is not binding, the FDA follows the advice of its advisory committee about 80 percent of the time.
This case is not merely significant because it is a disappointment for many patients...
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