The FDA has declined to approve MDMA, known as ecstasy, as a treatment for post-traumatic stress disorder (PTSD), Lykos Therapeutics announced Friday.
Experts view this decision as a minor setback for the use of psychedelics in mental health treatment. Despite significant political pressure, this marks the first time the FDA considered a Schedule 1 psychedelic for medical use. Approval would have been the first new PTSD treatment in over two decades.
Lykos Therapeutics sought FDA approval for MDMA as part of a treatment regimen with talk therapy. However, an independent advisory committee declined to recommend approval in June, citing insufficient evidence of safety and efficacy, poorly designed studies, and allegations of misconduct during trials.
The FDA’s decision highlights the scrutiny psychedelics face for medical approval in the U.S. Lykos plans to request reconsideration after conducting an additional phase 3 clinical trial to address FDA concerns. The company expressed disappointment, emphasizing the unmet need for PTSD treatments.
Despite this rejection, experts remain optimistic about the future of psychedelic therapies. There are numerous MDMA trials in progress, and psychedelics like psilocybin are showing promise. Innovations like neuroplastogens aim to retain therapeutic benefits while minimizing side effects.
In July, nearly 800 veterans sent a letter to President Joe Biden advocating for MDMA approval for PTSD. A bipartisan group of 80 lawmakers also urged the FDA to consider the treatment.
While some experts express concern about political pressure on the FDA, the decision underscores the need for rigorous research to ensure the safety and efficacy of psychedelic therapies.
