Following an April 18 executive order from President Trump directing the Department of Health and Human Services to accelerate access to treatments for serious mental illness, the FDA announced it is issuing national priority vouchers to three companies studying psychedelic medications. Psilocybin, derived from magic mushrooms, is being studied for treatment-resistant depression and major depressive disorder. Methylone is being studied for PTSD, and the FDA is also allowing an early-phase clinical study of noribogaine hydrochloride, a derivative of ibogaine, for alcohol use disorder.
According to emergency care doctor Jonathan Leake, who is certified in psychedelic-assisted therapy and co-founder of Derive Health, which offers ketamine therapy, many of these treatments help reactivate parts of the brain. “The way I kind of think about this is we’re kind of rebalancing the brain through that neurotransmitter effect, and then we’re kind of pouring fertilizer on it so it can grow these connections and really stick,” Leake said. He emphasized that patients should be supervised by medical professionals during treatment, as these drugs could create an out-of-body experience. “We really need to make sure that we have trained physicians and therapists who know how to work with these medicines so that we can kind of extract the most benefit from it, right? And not actually do more harm or cause more damage by just giving the medicine without any support,” Leake said.
Clinical trials are already underway in the United States. The Scottsdale Research Institute in Arizona is studying psilocybin for treatment of PTSD. Retired Glendale Fire Captain Mark Herrman participated in the trial and reported positive results. “I show up different as a father, as a son. I have a peace about me now that I didn’t have before. I wouldn’t be here today if it wasn’t for psilocybin,” Herrman said.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.foxcarolina.com/2026/05/01/fda-fast-tracks-psychedelic-drugs-mental-health-treatment/