The Food and Drug Administration (FDA) declined on Friday to approve MDMA-assisted psychotherapy as a treatment for post-traumatic stress disorder (PTSD). The agency has asked Lykos Therapeutics, which submitted the new drug application (NDA) in February, to conduct an additional Phase 3 clinical trial, which would take years and millions of dollars. It is a major setback that dismayed veteran advocates and others who see MDMA as a potentially life-changing psychotherapeutic catalyst for people struggling with longstanding psychological challenges that currently approved treatments have not adequately addressed.
"The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades," said Amy Emerson, CEO of Lykos Therapeutics, a company created by the Multidisciplinary Association for Psychedelic Studies (MAPS), in a press release. "While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature."
