FDA ixnays MDMA, papers retracted

The US Food and Drug Administration has rejected Lykos Therapeutics’ application to use methylenedioxymethamphetamine (MDMA) as a treatment for post-traumatic stress disorder. The agency has requested that Lykos conduct another Phase 3 trial. Three papers testing the therapy in the journal Psychopharmacology have been retracted because of concerns about data integrity. The journal says some researchers associated with the Multidisciplinary Association for Psychedelic Studies did not “fully declare a potential competing interest.” Stat News reported than an independent think tank raised concerns over whether severe adverse events were fully described in the data. Finally, the journal cites a specific site where “unethical conduct” took place. Stat News says a trial participant reported that an unlicensed therapist sexually assaulted them. Lykos says the research in the retracted papers wasn’t included in their FDA application.