Jack E Henningfield

2 months ago | gpsych.bmj.com | Jérémie Richard |Albert Garcia-Romeu |Jack E Henningfield

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.1 In principle, the FDA’s expanded access pathway could enable broader access to investigational treatments as clinical trials continue.