STAT+: Tracking the FDA advisory panel on MDMA therapy for PTSD

Good morning, and welcome to STAT’s live blog of the Food and Drug Administration’s scientific advisory committee meeting to review safety and efficacy data for MDMA-assisted psychotherapy to treat post-traumatic stress disorder. The discussion will start at 8:30 a.m. ET and run until about 5:30 p.m. (here’s an agenda). We published an in-depth story on Friday about what to expect today, but here are the basics:

MDMA is the first Schedule I psychedelic to be considered by the FDA — meaning that, if it’s approved, it would no longer meet the Drug Enforcement Administration’s Schedule I definition of having “no medical benefit.” After years of excitement and conversation about the potential for psychedelics to treat mental illness, this is a huge moment for the field and the burgeoning multibillion-dollar psychedelics industry.

As the first new PTSD treatment to go up for review in 25 years, this is also potentially a big moment for people with severe trauma that hasn’t responded to existing therapies.

Continue to STAT+ to read the full story…

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