April 24 (UPI) — The Food and Drug Administration announced regulatory actions Friday to support development of serotonin-2A agonists and related products, including psychedelic drugs.
On Saturday, President Donald Trump signed an executive order to speed up research on psychedelic drugs for mental health disorders.
“Today’s order will ensure that people suffering from debilitating symptoms might finally have a chance to reclaim their lives and lead a happier life,” Trump said during the signing.
Friday, the FDA said it is issuing national priority vouchers to three companies studying: psilocybin for treatment-resistant depression and major depressive disorder; and methylone for post-traumatic stress disorder.
“We are accelerating the research, approval, and responsible access to promising mental health treatments — including psychedelic therapies like ibogaine — to confront our nation’s mental health crisis head-on, especially for our veterans,” said Health and Human Services Secretary Robert F. Kennedy Jr. “The FDA will prioritize therapies with Breakthrough Therapy designation, where early evidence shows meaningful improvement over existing options for serious mental illness.”
The agency is also allowing an early-phase clinical study of noribogaine hydrochloride after an Investigational New Drug submission. The sponsor of the research is investigating noribogaine as a possible treatment for substance use disorder and other conditions.
This will allow the company developing the new drug, DemeRx NB, to begin a Phase I clinical study of the drug in a monitored, clinical setting in the United States.
“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,” said FDA Commissioner Marty Makary in a statement. “As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence. We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency.”