FDA Fast-Tracks Review Process for Three Psychedelic Drugs
- The FDA awarded priority review vouchers to three psychedelic drugs aimed at treating mental health conditions, including two psilocybin-based drugs for depression and one methylone-based drug for PTSD.
- The priority review vouchers shorten the review period but do not guarantee drug approval.
- The FDA also approved initial testing for an ibogaine-based drug, DemeRx, to treat alcohol use disorder.
- This move follows an executive order from President Donald Trump directing the FDA to expedite reviews of psychedelics as mental health treatments, despite these substances currently being classified as Schedule I drugs.
The federal Food and Drug Administration (FDA) announced on Friday that it awarded priority review vouchers to three psychedelic drugs being developed to treat certain mental health conditions, the Associated Press reports.
The drugs include two psilocybin-based drugs manufactured to treat depression, and one psychedelic made using methylone, a similar substance to MDMA, which is designed to treat post-traumatic stress disorder (PTSD). They are not guaranteed to receive approval with the vouchers, but the review period for the drugs should be shortened.
“We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency.” — FDA Commissioner Marty Makary, in a statement
The FDA has also approved initial testing for an ibogaine-based drug, DemeRx, as a treatment for alcohol use disorder, the report said.
The announcement comes about a week after President Donald Trump (R) signed an executive order directing the FDA to expedite the review of psychedelics, including psilocybin and ibogaine, as potential mental health treatments.
Currently, all psychedelics are Schedule I under the Controlled Substances Act, reserved for drugs with “a high potential for abuse” and “no currently accepted medical use” in the U.S.