Psychedelic drug MDMA faces questions as FDA considers approval for PTSD

This photo provided by the Center for Psychedelic Therapy Research shows a Yehuda Lab MDMA-assisted therapy treatment room at the James J. Peters Department of Veterans Affairs Medical Center in the Bronx borough of New York.

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 other substances the federal government deems prone to abuse and devoid of any medical use.that are expected to be reviewed by the FDA in coming years.

The group studied its approach in 195 adults with moderate-to-severe PTSD who were randomly assigned to undergo the therapy with MDMA or with a dummy pill. Following treatment, patients who received MDMA had significantly lower PTSD scores and were more likely to be in remission. The most common side effects of MDMA included headache, nausea, muscle tightness and decreased appetite. More serious issues included heart palpitations and elevated blood pressure, which FDA reviewers said had the “potential to trigger” life-threatening heart problems.

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