FDA advisory committee rejects MDMA for PTSD

The FDA advisory committee rejected MDMA-assisted therapy as a treatment for PTSD due to insufficient evidence, despite its promising potential. The drug application for MDMA was submitted by Lykos Therapeutics, but committee members raised concerns about gaps in data, alleged misconduct, and the diversity of the study population. While some members acknowledged the potential benefits of MDMA, others expressed skepticism and voted against recommending it as a treatment for PTSD. The FDA is expected to make a final decision in August, with some believing that further research is needed to better understand the effectiveness and risks of MDMA-assisted therapy.

Source link