Expanded access to psychedelic treatments: comparing American and Canadian policies.
Jérémie Richard, Albert Garcia‐romeu, Jack E Henningfield
Gen Psychiatr February 19, 2025 DOI: 10.1136/gpsych-2024-101894 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Commentary or news analysis Peer reviewed |
|---|---|
| Keywords | Psychedelic access Psychedelic policy Compassionate use |
| Citations | 7 |
| Key points | The FDA's requirement for an additional phase III study could delay the potential approval of midomafetamine for PTSD by several years. |
Abstract
The United States Food and Drug Administration’s (FDA’s) August 2024 determination that an additional phase III study will be required to consider the approval of midomafetamine for the treatment of post-traumatic stress disorder (PTSD) could delay the potential approval of this promising treatment by several years.