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University closes PTSD studies after complaints from drug regulator

BMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i3891 (Published 12 July 2016) Cite this as: BMJ 2016;354:i3891
  1. Owen Dyer
  1. Montreal

Eight studies into an experimental drug to treat post traumatic stress disorder (PTSD) have been halted by New York University (NYU) and their principal investigator has resigned after a letter from the US Food and Drug Administration (FDA) warned that lapses in the conduct of the research jeopardized “subject safety and welfare, and raised concerns about the validity and integrity of the data collected at [the] site.”

The studies, sponsored by Pfizer, were trials of a fatty acid amide hydrolase (FAAH) inhibitor, a drug with effects on cannabinoid receptors, as a potential treatment for distress in patients with traumatic memories.

The FDA warning came in a …

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