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.
Voelker R. Learning About French Trial Death. JAMA. 2016;315(9):861. doi:10.1001/jama.2016.1247