FDA rejects psychedelic MDMA-assisted therapy for PTSD
The FDA declined to approve MDMA-assisted therapy, commonly known as ecstasy, as a treatment for PTSD.
The Food and Drug Administration declined to approve MDMA, commonly known as ecstasy, as a treatment for post-traumatic stress disorder, drugmaker Lykos Therapeutics said Friday.
Experts and advocates say the decision is a minor setback in the growing movement to use psychedelics in the treatment of certain mental health conditions.
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.
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