The Food and Drug Administration has declined to recommend approval for the use of MDMA, more popularly known as molly or ecstasy, to treat post-traumatic stress disorder or PTSD, despite advocates pushing for the inclusion of psychedelics, or hallucinogens, in treating mental health disorders.
To secure the approval of the drug, two votes are needed—one for the efficacy of the MDMA and the other from the Psychopharmacologic Drugs Advisory Committee of the agency to signify the drug's safety, and an approval of MDMA would mean having the first new treatment for PTSD in more than 20 years. Yet the turnout of the votes reflects the panel's struggle to balance the need for the introduction of a new PTSD treatment vis-a-vis the data submitted by Lykos Pharmaceuticals, which they say was impaired by poor study design and inconsistencies. Added to that, allegations of misconduct also marred the results.
