FDA's MDMA rejection delays PTSD treatment options

The FDA’s recent rejection of midomafetamine (MDMA), along with mental-health therapy, for the treatment of post-traumatic stress disorder (PTSD) came as no surprise. Lykos Therapeutics, formerly MAPS, has come under attack for missing safety data, therapist misconduct and a culture of psychedelic evangelism. The journal Psychopharmacology retracted three papers about MDMA-assisted psychotherapy. The FDA’s recommendation that Lykos repeat the studies is unavoidable, but the FDA should engage more effectively as well.