FDA Widens Probe of Ecstasy-Based Drug Studies
August 29, 2024

(Wall Street Journal) – Agency investigators asked people involved in the trials whether side effects went unreported
The Food and Drug Administration is ramping up its investigation of the clinical trials that tested an Ecstasy-based therapy, after the agency earlier rejected the application for its approval. FDA investigators this week interviewed four people about the clinical trials sponsored by company Lykos Therapeutics, people familiar with the matter said. Investigators asked about whether side effects went unreported.
The Wall Street Journal has reported that the Lykos studies missed serious side effects in study subjects, including suicidal thoughts. (Read More)