Psychedelic drug MDMA faces questions as FDA considers approval for PTSD
Federal health regulators are set to review the first request to approve the mind-altering club drug MDMA as a treatment for PTSD
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 decadeslong 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 also raised several safety concerns, including MDMA's heart risks and potential for abuse.
The outside experts will take a nonbinding vote on the drug’s overall benefits and risks during Tuesday's meeting. The FDA will make the final decision, likely in August.
Antidepressants are now the only FDA-approved drugs for post-traumatic stress disorder, which is closely linked to depression, anxiety and suicidal thinking and is more prevalent among women and veterans
If approved, MDMA would be reclassified as a prescription medicine and made available to specially certified doctors and therapists. Currently, the drug is in the same ultra-restrictive category as heroin and
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