FDA rejects MDMA-assisted therapy for PTSD treatment – a drug researcher explains the challenges psychedelics face

A growing body of evidence points to MDMA's therapeutic potential for managing an array of hard-to-treat conditions like PTSD and depression. Antonio Ciufo/Moment via Getty Images

Drugmaker Lykos Therapeutics announced on Aug. 9, 2024, that the Food and Drug Administration declined to approve the company’s application for the use of MDMA-assisted therapy in the treatment of post-traumatic stress disorder. It is the first such decision issued on a psychedelic drug application.

Many investors and researchers have been predicting a psychedelics boom, with MDMA being just the first of a number of psychedelics in the drug development pipeline.