2 papers in the library · 15 citations · publishing 2024
Science (New York, N.Y.) August 16, 2024 Kai Kupferschmidt 12 citations
The FDA's rejection of Lykos's application for a PTSD therapy using MDMA may push rival companies to change their business strategies, potentially speeding up a move toward different approaches in psychedelic medicine development.
Science (New York, N.Y.) June 14, 2024 Kai Kupferschmidt 3 citations
After the FDA rejected MDMA-assisted therapy for PTSD, researchers are analyzing what went wrong and how to improve future clinical trials. The negative vote highlights concerns about study design, potential bias, and the need for more rigorous methodologies in psychedelic research. Lessons include the importance of adequate blinding, managing expectancy effects, and ensuring data integrity. The field must address these challenges to advance regulatory approval for psychedelic treatments.