The FDA declined to approve a new drug application for MDMA as a treatment for PTSD. The FDA cited insufficient data, requesting additional clinical trial data to assess safe and effective use. The initial application presented positive data from two late-stage clinical trials that used MDMA in combination with talk therapy to treat PTSD, the FDA noted that participants appeared to experience rapid and clinically meaningful, durable improvement in their PTSD symptoms. However, the FDA considered the trial data on efficacy of MDMA to be blurry and had concerns about safety data. The drug sponsor of the MDMA trial, Lykos, has stated they will work diligently to address the FDA concerns and supporters of MDMA as PTSD treatment are confident it will eventually be approved.
