Efforts to make MDMA legally available as a psychotherapeutic catalyst hit a daunting roadblock in August. The Food and Drug Administration (FDA) declined to approve a new drug application submitted in February by Lykos Therapeutics, a company created by the Multidisciplinary Association for Psychedelic Studies (MAPS).
The FDA was following the recommendation of an advisory panel that had expressed several concerns about two Phase 3 studies of MDMA's safety and effectiveness in treating post-traumatic stress disorder (PTSD), including inadvertent unblinding of subjects, potential underreporting of adverse events, and allegedly inadequate assessment of MDMA's abuse potential. The FDA requested an additional Phase 3 trial, which would take years and millions of dollars. Lykos described that request as "deeply disappointing," saying it hoped existing evidence could resolve the agency's concerns.
