The FDA declined to approve a new drug application for MDMA as a treatment for PTSD.

MDMA – known also as ecstasy or molly – is a psychedelic drug, currently classified as a schedule I drug. While it can be abused for the feelings of euphoria it can cause, clinical research has found that MDMA presents strong potential for the treatment of certain mental illnesses, when effectively utilized in a clinical setting.

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 FDA has declined to discuss the decision or release the letter sent to researchers outlining its reasoning, citing confidentiality rules.

The FDA previously granted MDMA breakthrough therapy status for its potential to treat PTSD and worked with clinicians to help guide the framework of clinical trials.

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.