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.
