BIA 10-2474 is reported to be an inhibitor of FAAH, an enzyme involved in cell function in the nervous system. Previous studies centering on FAAH inhibitors have investigated their potential therapeutic use in a number of neurological disorders. The recent study in France is the first human fatality following exposure to an FAAH inhibitor. 

Fatalities in phase 1 trials conducted in the U.S. are extremely rare. Before any human volunteers can be enrolled in a phase 1 study in the U.S., sponsors must submit rigorous laboratory and animal data to the FDA in an IND application. A 30-day waiting period after IND submission allows the FDA to review safety data and determine if the it is reasonably safe to proceed testing in human volunteers.

For more information visit FDA.gov


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