The Food and Drug Administration on Friday declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder, dealing a serious blow to the nascent field of psychedelic medicine and dashing the hopes of many Americans who are desperate for new treatments.
An additional clinical trial could add years, and millions of dollars, to the approval process.
If approved, MDMA would have become the first psychedelic compound to be regulated by federal health authorities.
“This is an earthquake for those in the field who thought F.D.A.
approval would be a cinch,” said Michael Pollan, the best-selling author and co-founder of the UC Berkeley Center for the Science of Psychedelics.
Persons:
F.D.A, ”, Michael Pollan
Organizations:
Drug Administration, Lykos Therapeutics, UC Berkeley Center, Psychedelics