FDA Rejects MDMA Therapy Application, Calls for More Research
Last week, the U.S. Food and Drug Administration (FDA) made the decision not to approve MDMA-assisted therapy for post-traumatic stress disorder. This decision comes just months after advisors to the agency voted against evidence supporting MDMA therapy. The agency’s decision was based mainly on concerns about issues with clinical research. The advisors’ decision to not approve the treatment put the agency in a bind, given that historically, it sides with this committee. The recent news was a huge blow to Lykos Therapeutics and the broader movement focused on bringing psychedelics into mainstream mental-health care. Instead, the FDA directed that the…