The FDA is issuing national priority vouchers to three companies studying psychedelic drugs to treat serious mental illness.
The vouchers were issued to companies studying psilocybin for treatment-resistant depression and major depressive disorder as well as methylone for post-traumatic stress disorder, following President Donald Trump’s April 18 executive order. The order directed federal agencies to accelerate research, regulatory review and access to psychedelic drugs, including ibogaine compounds, for serious mental illnesses.
The agency also allowed an early phase clinical study of noribogaine hydrochloride to proceed following an Investigational New Drug submission, according to an April 24 news release from the FDA. The study will evaluate the compound as a potential treatment for alcohol use disorder, marking the first U.S. clinical study of a derivative of ibogaine.
The FDA said its decision to allow the study does not indicate the drug is approved or proved safe or effective, according to the release. The agency will continue reviewing data as it becomes available.
The agency also plans to release final guidance for sponsors developing serotonin-2A agonists and related products, outlining recommendations for clinical trial design, data collection, patient monitoring and other considerations, according to the release.
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