RFK, Jr., puts psychedelics on fast track to FDA review and approval
The U.S. FDA is fast-tracking review and approval for three companies studying psilocybin and methylone as treatments for depression and PTSD. The FDA's announcement follows an executive order by President Donald Trump to speed up the development and approval process for psychedelics.
The U.S. Food and Drug Administration announced it is fast-tracking the review and approval process for three companies studying psilocybin and methylone as treatments for depression and post-traumatic stress disorder (PTSD). The companies are investigating psilocybin as a therapy for treatment-resistant depression and major depressive disorder, while methylone is being studied as a potential treatment for PTSD. The FDA also approved a phase 1 clinical trial of noribogaine hydrochloride, a form of the psychoactive substance ibogaine, to investigate its use as a treatment for alcohol use disorder. President Donald Trump signed an executive order directing the FDA to speed up the development and approval process for psychedelics. Secretary of Health and Human Services Robert F. Kennedy, Jr. stated that the FDA will prioritize treatments with enough early evidence to suggest they are more effective than existing therapies for mental health conditions.
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