AXIOS June 3, 2024
The challenges of mainstreaming psychedelic therapies for conditions like PTSD, anxiety and major depression will be brought home this week when federal drug advisers scrutinize what could be the first such treatment to gain approval in the U.S.
Why it matters: While regulators have laid out how they think clinical trials can assess hallucinogenic substances like ecstasy and magic mushrooms as behavioral health treatments, there’s limited data to judge their safety and effectiveness, and there’s a high risk for misuse.
- Psychedelics have major effects on brain activity, which is why they’re tightly regulated and researchers to date have struggled to meet best scientific practices.
Driving the news: A Food and Drug Administration panel of outside experts on Tuesday...