The Food and Drug Administration (FDA) has found that the investigational new drug, BIA 10-2474, which was involved in one death and four hospitalizations in a French trial, has a unique toxicity that does not extend to other drugs in the same class.
BIA 10-2474, manufactured by the Portuguese company Bial, belongs to the fatty acid amide hydrolase (FAAH) inhibitor class of drugs. The enzyme FAAH has been studied for its potential therapeutic use in a variety of disorders, most often neurological. The four injured participants in the French trial were hospitalized due to neurological damage.
The FDA initiated their comprehensive safety review of BIA10-2474 back in January when news from the first trial emerged. They will now work with sponsors to determine an appropriate pathway for FAAH inhibitors that will be investigated in the U.S. Participants and investigators working on FAAH trials will also be fully informed of the risks and potential benefits.
Fatalities in Phase 1 clinical trials in the U.S are extremely rare due to regulations that stipulate rigorous lab and animal data be submitted before any human volunteers are enrolled.
For more information visit FDA.gov.