FDA Grants Breakthrough Designation For Blood Tests
The FDA has granted breakthrough therapy designation to MDMA-assisted psychotherapy for the treatment of certain conditions. Researchers are currently studying the use of substances including LSD, Ketamine, MDMA, and Ibogaine. The agency noted a need to better understand potential complications of using psychedelics in medical settings. This follows a 2024 FDA rule against MDMA for PTSD. The exact mechanism of how MDMA works in the brain remains unclear, according to the source. The designation follows research involving a sample size of 30 per disorder using 'leave-one-out' analyses.
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Sources · 7 independent
BBC World Service
“FDA granted breakthrough therapy designation to MDMA, assisted psychotherapy for treatment of...”
BBC World Service
“FDA granted breakthrough therapy designation to MDMA, assisted psychotherapy for treatment of... doing research with LSD, Ketamine, MDMA, Ibogaine”
BBC WS backup
“the FDA used in 2024 to rule against the MDMA for PT.”
BBC World Service
“argument the FDA used in 2024 rule against the MDMA for PT. also need to know exactly how they work in the brain, you know, that's still not clear.”
Bluesky Social
“FDA grants breakthrough device designation for schizophrenia/bipolar bloodtests, based on below paper with n=30 per disorder”
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