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News From the Food and Drug Administration
March 1, 2016

Learning About French Trial Death

JAMA. 2016;315(9):861. doi:10.1001/jama.2016.1247

Officials from the FDA conferred with European regulators after 1 person died and several others developed severe neurological problems during a phase 1 clinical study in France (http://1.usa.gov/1SHVWkJ).

The study focused on BIA 10-2474, an investigational new drug manufactured by Bial, a Portuguese pharmaceutical company. The drug reportedly is a long-acting inhibitor of fatty acid amide hydrolase (FAAH), an enzyme involved in nervous system cell function. Although FAAH inhibitors have been studied for their therapeutic potential in a number of neurological disorders, FDA officials said the fatality in France was the first known death after exposure to an FAAH inhibitor.

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