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 via PubMed Central
Summary
AI-generated from the abstractThe FDA's August 2024 decision that an additional phase III study is needed before considering approval of midomafetamine for PTSD may postpone the potential approval of this treatment by several years.
Study at a glance
| Characteristics | Commentary or news analysis Peer reviewed |
|---|---|
| Keywords | Psychedelic access Psychedelic policy Compassionate use |
| Citations | 7 |
| Key finding | 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.