The FDA announced on Friday, April 24th that three psychedelic drugs have been granted expedited review vouchers, the first psychedelic treatments to benefit from an executive order signed last week by President Trump easing federal restrictions on psychedelic substances. The FDA granted these initial vouchers to two companies studying the use of psylocibin for treatment-resistant depression and a third company studying methylone (a drug related to MDMA) as a treatment for post-traumatic stress disorder.
These psychedelic drugs are receiving accelerated review under the FDA’s Commissioner’s National Priority Voucher program, an initiative introduced last year to provide faster reviews to treatments addressing “national priorities.” While expedited review does not guarantee FDA approval, it does shorten an arduous approval timeline from months to weeks.
The FDA also announced this week that it has authorized early testing of a drug derived from ibogaine. Ibogaine, a controversial drug which has developed a following among veterans suffering from trauma and addiction despite known cardiac risks, is being studied as a treatment for alcohol use disorder.
Read the full article at apnews.com/article/psychedelics-trump-fda-kennedy-drugs-mdma-afd00baa39f4300e4631d1f3eed27b7f