On Friday, 8/9, the FDA released its decision to not approve MDMA-assisted therapy for PTSD, stirring ongoing debate in the psychedelic research community. Many in the field were optimistic when Lykos Therapeutics initially submitted their New Drug Application in Dec. 2023, pointing to promising Phase 3 trials showing that over 70% of participants no longer met PTSD criteria after MDMA treatment. Anticipation of approval lessened significantly in June, however, when the FDA’s advisory committee recommended against approval of MDMA-assisted therapy. Despite support from veterans, mental health professionals, and politicians, the FDA cited concerns about the quality of the research and overall safety and efficacy of the drug. Lykos says it plans to seek reconsideration of the decision. But this process will delay the therapy’s availability for years, at least.
While some experts view the FDA’s decision as overly cautious, fearing it could stifle innovation in psychedelic therapies, others believe that the rejection might prompt stronger competition and better research quality in the future. The ruling also highlights the broader policy and regulatory challenges facing the psychedelic industry, bringing to light concerns about data quality, clinical trial designs, and the influence of public pressure on regulatory decisions. Despite this setback, Lykos says it remains committed to pushing forward with further research and regulatory efforts. Meanwhile others have been suggesting that psilocybin may now be on track to gain approval ahead of MDMA.
Emerge Law Group shareholder Sean Clancy had this to say: “FDA’s decision is not a surprise, given the advisory committee’s prior recommendation against approval. But it certainly is a disappointment for Lykos and others wishing for MDMA to be legalized as mental health medicine. Many are speculating about FDA’s exact rationale. And although Lykos will ask FDA to reconsider, it’s safe to assume that Lykos probably needs to revisit its methods and protocols to craft a better case for MDMA’s approval as a medicine. That will be expensive and time consuming. As FDA’s conclusion reverberates around the world of psychedelics, I will be interested to see how this affects psychedelic operators outside of pathology-focused medical frameworks.”
