Efforts to make MDMA legally available as a psychotherapeutic catalyst hit a daunting roadblock on Tuesday when an expert panel overwhelmingly voted to recommend that the Food and Drug Administration (FDA) reject a new drug application that Lykos Therapeutics submitted in February. Members of the panel expressed several concerns about two Phase 3 studies of MDMA's safety and effectiveness in treating post-traumatic stress disorder (PTSD), including unblinding of subjects, potential underreporting of adverse events, and allegedly inadequate assessment of MDMA's abuse potential.
"We are disappointed in today's vote given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention," said Amy Emerson, CEO of Lykos Therapeutics, a company created by the Multidisciplinary Association for Psychedelic Studies (MAPS). "We remain committed to working with the FDA to address outstanding questions so that we may find a path forward to ensure the responsible and careful introduction of MDMA-assisted therapy into the healthcare system, if approved."
