MDMA as a medicine
Research into midomafetamine as a medicine has focused on its potential as a catalyst to support psychotherapy by helping diminish the brain’s fear response, meaning patients can access and process painful memories without being overwhelmed.12
As a medicine, it is intended that it is used alongside or to support talking therapies, where other medicines, such as selective serotonin reuptake inhibitors (SSRIs) have been unsuccessful.10
in July 2023, Australia authorised midomafetamine for treating post-traumatic stress disorder (PTSD). As psychedelic-assisted therapies are not well established, Australia’s Therapeutic Goods Administration (TGA) is restricting prescribing to psychiatrists who are in the TGA’s Authorised Prescriber scheme.2
Drug trials have also been taking place in the United States with the aim of authorising midomafetamine-assisted therapy. However, in August 2024, the Food and Drug Administration (FDA) decided not to license midomafetamine at this stage for use in PTSD, requiring further phase 3 data. This was seven years after it granted ‘breakthrough status’ for the Lykos Therapeutics midomafetamine preparation in 2017, putting it on a fast-track process after promising phase 2 trial outcomes.10,13,14