Only two drugs are formally approved for post-traumatic stress disorder, or PTSD , and they don’t help everyone. A lack of effective treatment options has led some patients to seek out the psychedelic drug MDMA, also known as ecstasy, to help relieve their symptoms when traditional medications and therapy don’t work. In the US, momentum has been growing to legalize MDMA and other psychedelics.
Lykos Therapeutics, which has been testing MDMA alongside psychotherapy in clinical trials for years, had a chance this week to prove that the combination is effective at treating PTSD. But at a June 4 meeting , a panel of advisors to the US Food and Drug Administration overwhelmingly voted that there wasn’t enough evidence to recommend its approval. Just two of the 11 committee members were convinced that the treatment was effective, and only one said its benefits outweighed the risks.
Though trial results were generally positive, FDA advisors cited a long list of problems with the data Lykos presented. For one, because it’s not hard to tell whether or not you’re experiencing the effects of a psychedelic drug, participants likely knew if they received MDMA or placebo, which could have biased how they reported feeling afterwards. The psychotherapy administered during the trial was also under fire, with advisors saying it wasn’t standardized across providers and pointing to misconduct allegations as cause for concern.
And many participants had tried MDMA before, potentially m.
