MDMA-assisted therapy for PTSD one step closer to FDA approval

The psychedelic drug MDMA, also called ecstasy or Molly, showed promise in a late-stage clinical trial for people with severe post-traumatic stress disorder (PTSD), inching the drug closer to medical approval for the condition, The New York Times reported.

The study, soon to be published in the journal Nature Medicine, included 90 people with PTSD who all underwent talk therapy during the trial; these participants included combat veterans, first responders and victims of sexual assault, mass shootings, domestic violence or childhood trauma, the Times reported.

After two introductory sessions with therapists, each participant completed three 8-hour sessions at which they received either MDMA or a placebo. The trial was double-blinded, meaning neither the therapists nor participants knew which drug had been given. In the end, data showed that patients who received MDMA experienced greater relief from their symptoms than the placebo group, and two months after the treatment ended, 67% no longer met the diagnostic criteria for PTSD, whereas only 32% of the placebo group showed this level of improvement.
Now, to be fully approved by the Food and Drug Administration (FDA), the MDMA-assisted psychotherapy must garner positive results in a second late-stage clinical trial, to replicate the results of the first trial, the Times reported. The trial is already in progress and includes 100 participants, meaning FDA approval for the treatment could come as soon as 2023.

Read more about the recent clinical trial in The New York Times. https://www.nytimes.com/2021/05/03/health/mdma-approval.html?action=click&module=Top%20Stories&pgtype=Homepage