US EditionUS FDA moves to fast-track psychedelic drugs after Trump order
The vouchers could cut FDA review from months to weeks as the agency backs psilocybin and methylone programs and opens a first U.S. ibogaine study.
- On Friday, the FDA issued national priority vouchers to three companies studying psychedelic medicines for treatment-resistant depression, major depressive disorder, and post-traumatic stress disorder, aiming to fast-track regulatory reviews.
- President Donald Trump signed an executive order Saturday directing FDA Commissioner Dr. Marty Makary to prioritize psychedelic drugs granted "breakthrough therapy" status, a designation reserved for therapies showing substantial promise over existing options.
- The FDA also permitted the first United States clinical study of ibogaine, allowing Miami-based DemeRx to research noribogaine hydrochloride as a potential treatment for alcohol use disorder affecting nearly 28 million Americans.
- Treatments will be restricted to controlled, hospital settings under clinical supervision, not dispensed for home use. Officials emphasized rigorous oversight is essential to ensure patient safety and effectiveness.
- The American Psychiatric Association welcomes research but advocates for rigorous clinical evidence, cautioning that potential downsides must be evaluated before these therapies move beyond approved research settings.
129 Articles
129 Articles
FDA plans ultra-fast review of 3 psychedelic drugs
WASHINGTON — The Food and Drug Administration said Friday it will offer ultra-fast review to three psychedelic drugs being developed to treat mental health conditions, including depression, the latest step by the Trump administration toward possible approval of the experimental…
Hallucinogenics are illegal under federal law but that isn't stopping the FDA from fast tracking 3 psychedelic drugs to treat mental health
The Food and Drug Administration said Friday it will offer ultra-fast review to three psychedelic drugs being developed to treat mental health conditions, including depression, the latest step by the Trump administration toward possible approval of the experimental treatments. President Donald Trump signed an executive order last weekend directing the FDA and other federal agencies to speed research and loosen restrictions on psychedelics, a cla…
The FDA Fast-Tracks Its Review of Psilocybin and Methylone, 2 Promising Psychedelics
It has been six days since President Donald Trump signed an executive order aimed at facilitating regulatory review of psychedelics that have shown potential as psychotherapeutic catalysts. As promised then, the Food and Drug Administration (FDA) today issued "national priority vouchers" for two psychedelics: psilocybin as a treatment for depression and methylone (a.k.a. MDMC) as a treatment for post-traumatic stress disorder (PTSD). The FDA had…
Measures include the development of medications containing psilocybin, the ingredient in magic mushrooms, as well as methylone, a synthetic cathinone used as a substitute for MDMA.
FDA Plans Quick Review of Psychedelic Drugs as Mental Health Treatments
The Food and Drug Administration on April 24 said it will seek fast trials for three psychedelic drugs, including psilocybin, one week after President Donald Trump’s directive to accelerate access to psychedelic treatments for mental health conditions. Three national priority vouchers are being issued, including two for psilocybin, the FDA said in a statement. One of the companies receiving a voucher is developing psilocybin for depression that …
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