ARTICLE | Clinical News

FDA: Bial-Portela's FAAH inhibitor has "unique toxicity"

August 12, 2016 7:00 AM UTC

In its safety review of fatty acid amide hydrolase ( FAAH) inhibitors, FDA concluded that BIA 10-2474 from Bial-Portela & Ca. S.A. (S. Mamede do Coronado, Portugal) "exhibits a unique toxicity that does not extend to other drugs in the class." The agency reviewed FAAH inhibitors after BIA 10-2474 led to the development of serious neurological issues in trial volunteers in a French Phase I study, leading to the death of one subject and the halt of the study in January (see BioCentury Extra, Jan. 15).

FAAH is an enzyme that degrades endocannabinoids, neurotransmitters that are the natural ligands of cannabinoid receptors. ...