FDA issues vouchers to 3 companies to help fast track review of potential psychedelic medications
The Food and Drug Administration (FDA) announced on Friday It's 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 vouchers mean the FDA has 60 days to review the medications for approval.
"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.
This is the first time the FDA has allowed a clinical study in the U.S. of a derivative of ibogaine, which is derived from the African Tabernanthe iboga shrub, the press release said.
Noribogaine hydrochloride is being investigated as a potential treatment for alochol use disorder, according the FDA.
The FDA also said it intends "to release final guidance imminently to provide recommendations to sponsors developing these products" which will include recommendations for study design, data collection and patient monitoring.
"There is a growing recognition of the potential of psychedelic medications to address multiple different psychiatric conditions that are notoriously difficult to treat," said Dr. Tracy Beth Hoeg, acting director of the FDA's Center for Drug Evaluation and Research. "At the FDA we are showing our support of investigating the safety and efficacy of this class of drugs through today's actions."
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.
Currently, there are no classic psychedelic drugs approved for routine psychiatric care in the U.S.
A multitude of studies have suggested that psychoactive drugs, including cannabis, ketamine, psilocybin and midomafetamine (MDMA), may help treat PTSD and other mental health disorders.
However, most of these drugs are classified as Schedule I, meaning they have "no currently accepted medical use and a high potential for abuse," according to the Drug Enforcement Administration.
A 24-person 2022 study from John Hopkins Medicine followed patients with moderate to severe major depressive disorder who received psilocybin-assisted treatment for up to a year. Psilocybin is the main psychoactive ingredient in magic mushrooms.
Researchers found antidepressant effects from psilocybin and supportive psychotherapy may last at least a year in some patients. Administration required close monitoring in a controlled setting with a trained provider.
MDMA has shown some early promise in treating PTSD. However, in June 2024, a panel of independent advisers for the FDA voted against recommending approval of pharmaceutical version of MDMA -- along with therapy -- to treat the condition.
The Psychopharmacologic Drugs Advisory Committee appeared to have doubts about the safety and efficacy of the treatment, with the majority voting "no" on questions of data showing the drug is effective and that the benefits of MDMA outweigh the risks for the treatment of patients with PTSD.
Methylone is a synthetic stimulant related to MDMA that affects mood and energy but carries risks of addiction, heart strain, and other serious side effects.
ABC News' Liz Neporent contributed to this report.
