MDMA faces questions as FDA considers approval for PTSD [Video]

WASHINGTON — Federal health regulators are questioning the safety and evidence behind the first bid to use MDMA, the mind-altering club drug, as a treatment for PTSD, part of a decades-long effort by advocates to move psychedelic drugs into the medical mainstream.

The Food and Drug Administration posted its initial review of the drug Friday, ahead of a meeting of outside advisers who could help decide whether MDMA – currently illegal under federal law – becomes the first drug of its kind to win U.S. approval as a medication.

In their assessment, FDA scientists said that patients who received MDMA and talk therapy showed “rapid, clinically meaningful, durable improvements in their PTSD symptoms.” But they also called the research “challenging to interpret,” and questioned how long the benefits might last.

They said it’s difficult to know how much of the improvement came from MDMA versus simply undergoing intensive therapy and …