FDA Evaluates MDMA for PTSD Amid Safety Concerns and Study Issues
TL;DR Summary
The FDA has raised concerns about the health risks and study flaws in the use of MDMA, commonly known as Ecstasy, for treating PTSD. The agency's analysis highlighted issues such as bias in the studies and significant increases in blood pressure and pulse rates, which could lead to cardiovascular events. An independent advisory panel will review the application by Lykos Therapeutics for MDMA-assisted therapy next week. Approval of this treatment would represent a major shift in the regulation of psychedelic compounds.
- FDA Reviews MDMA Therapy for PTSD, Citing Health Risks and Study Flaws The New York Times
- Psychedelic drug MDMA faces questions as FDA considers approval for PTSD The Associated Press
- MDMA FDA Approval Would Make Ecstasy a Legal PTSD Treatment Bloomberg
- The FDA is weighing whether to approve MDMA for PTSD. Here's what that could look like for patients. CBS News
- MDMA therapy for PTSD faces crucial FDA panel meeting STAT
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