Expanded access to psychedelic treatments: comparing American and Canadian policies.
Jérémie Richard, Albert Garcia‐romeu, Jack E Henningfield
General Psychiatry 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.
Citations in the library
Cited by 9
- Addressing US Demand for Psychedelic Medicines in the Face of Scientific Uncertainty. The Journal of Law, Medicine & Ethics 2026
- Setting, context and the regulatory atmospheres of psychedelic medicine. International Journal of Drug Policy July 1, 2026
- Psychedelic therapy and cultural humility Translational Psychiatry February 27, 2026
- Advancing treatment paradigms: the role of psilocybin in managing major depressive disorder. Annals of Medicine and Surgery 2026
- From regulation to practice: A scoping review of prescribers’ roles in psilocybin-assisted therapy Drug Science Policy and Law October 1, 2026
and 4 more in the library
Cites 5
- MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nature Medicine October 1, 2023
- Adverse Events in Studies of Classic Psychedelics JAMA Psychiatry September 4, 2024
- Psychedelic-assisted psychotherapy to treat psychiatric and existential distress in life-threatening medical illnesses and palliative care. Neuropharmacology September 15, 2022
- Longitudinal experiences of Canadians receiving compassionate access to psilocybin-assisted psychotherapy. Scientific Reports July 17, 2024
- Pharmacotherapy of anxiety disorders in the 21st century: A call for novel approaches General Psychiatry December 1, 2019