FDA Fast-Tracks Review of 3 Psychedelic Drugs for Depression and PTSD
The FDA on Friday granted fast-track review status to three experimental psychedelic drugs designed to treat major depression and PTSD. The agency will issue priority review vouchers next week that could speed approval to just weeks instead of years.
The Food and Drug Administration on Friday approved expedited reviews for three experimental psychedelic drugs aimed at treating major depression and post-traumatic stress disorder.
FDA Commissioner Marty Makary announced at a Saturday press conference that the agency will soon issue priority review vouchers to three serotonin 2a agonists. This drug class includes psychedelics like LSD and psilocybin, the active ingredient in magic mushrooms.
The priority vouchers will allow these drugs to be reviewed and potentially approved in just weeks, rather than the typical years-long process. Makary said the fast-track decision comes after lobbying efforts and follows a Trump administration order to speed psychedelic drug reviews.
Traditional treatments for depression and PTSD don't work for everyone. About one-third of people with depression don't respond well to standard antidepressants. Researchers believe psychedelics could offer a breakthrough treatment option by affecting brain chemistry differently than current medications.
The three drugs are still experimental and must prove they are both safe and effective before reaching patients.
Millions of Americans suffer from depression and PTSD with limited treatment options. These psychedelic drugs could offer new hope for patients who don't respond to current medications like antidepressants.
The FDA will issue the priority vouchers next week. Clinical trials will continue to test safety and effectiveness.
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