(NEW YORK) — The Food and Drug Administration (FDA) announced on Friday it is issuing national priority vouchers to three companies to help fast-track the review of certain psychedelic medications.
The companies are studying psilocybin for treatment-resistant depression and major depressive disorder and methylone for post-traumatic stress disorder (PTSD).
“These medications have the potential to address the nation’s mental health crisis, including conditions like treatment-resistant depression, alcoholism and other serious mental health and substance abuse conditions,” FDA Commissioner Dr. Marty Makary said in a press release.
“As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence,” the statement continued. “We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency.”
The agency also announced it is allowing an early phase clinical study of noribogaine hydrochloride, the principal psychoactive substance of the drug ibogaine, to move forward following an Investigational New Drug submission.
The announcement comes after President Donald Trump signed an executive order over the weekend directing the FDA to expedite its review of certain psychedelics.
The order aims to accelerate research and approval of psychedelic-based therapies to help treat mental health conditions including PTSD, depression and addiction.
This is a developing story. Please check back for updates.
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