MDMA, also known as ecstasy or molly, is the first in a series of psychedelics that are expected to be reviewed in coming years.The FDA will decide whether MDMA - currently illegal under federal law - will become the first drug of its kind to win U.S. approval as a medication.
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. 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.
Until recently, psychedelic research was mainly funded by a handful of nonprofit advocacy groups, including Multidisciplinary Association for Psychedelic Studies, or MAPS. The company seeking approval for MDMA, Lykos Therapeutics, is essentially a corporate spinoff of MAPS, which conducted all the studies submitted for FDA review.
But FDA reviewers noted that the vast majority of patients correctly guessed whether they had received MDMA or a dummy pill, making it "nearly impossible" to maintain the so-called "blinded" objectivity considered essential for high-quality drug research. The agency also questioned how long the drug's benefits might last.
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