Will the FDA approve MDMA as a treatment for PTSD by the end of 2024?

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Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Midomafetamine Capsules

  • The FDA announced Thursday that it plans to hold a public advisory committee meeting on MDMA-assisted therapy on June 4

Seems like it's more a matter of when than if.

For comparison:

Market with close date in June 2024:





The psychedelic drug MDMA, also known as ecstasy or molly, has passed another key hurdle on its way to regulatory approval as a treatment for mental illness. A second large clinical trial has found that the drug — in combination with psychotherapy — is effective at treating post-traumatic stress disorder (PTSD). The results allow the trial’s sponsor to now seek approval from the US Food and Drug Administration (FDA) for MDMA’s use as a PTSD treatment for the general public, which might come as soon as next year.

Seems reasonably likely. For overseas precedent, here in Australia the Therapeutic Goods Administration approved MDMA for PTSD a few months ago.

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