FDA rejects Lykos’ MDMA treatment

The US FDA rejected Lykos Therapeutics’ application for MDMA-assisted therapy for PTSD, citing issues with clinical trial methodology and long-term safety and efficacy. The review raised concerns about the psychedelic drug’s psychoactive effects. Additionally, there were ethical issues in relation to the clinical trials. The FDA has requested additional phase 3 studies, delaying the therapy’s market prospects. Despite the setback, other companies, including Compass Pathways and MindMed, continue their efforts in psychedelic drug development.