Experimental FAAH Inhibitors Do Not Pose Safety Risk, FDA Concludes

The US Food and Drug Administration (FDA) has concluded that the toxicity of an experimental medicine in development to treat a host of clinical conditions, including hypertension and obesity, does not extend to other agents part of the same drug class.

Earlier this year, a phase I clinical trial in France testing BIA 10-2474 (Bial-Portela & Ca), which is a fatty acid amide hydrolase (FAAH) inhibitor, led to the death of one enrolled subject and hospitalization of five others, with four of the hospitalized individuals suffering significant neurological injury.

Working with the European Medicines Agency and Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), the French regulatory agency, the FDA states that “based on available information, BIA 10-2474 exhibits a unique toxicity that does not extend to other drugs in the class.”

The agency said they are working with sponsors testing other FAAH inhibitors to establish the “appropriate path forward” and to make sure that all healthy subjects, patients, and investigators participating in these clinical trials are aware of the risks and potential benefits of the drug class.

In addition to obesity and hypertension, BIO 10-2474 was also being tested for the treatment of anxiety, Parkinson’s disease, and chronic pain cause by multiple sclerosis. There were no clinical trials testing BIA 10-2474 in the United States.

 

 


 

Source:Food and Drug Administration. FDA finds drugs under investigation in the US related to French BIA-2474 drug do not pose similar safety risks. http://www.fda.gov/Drugs/DrugSafety/ucm482740.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Published on: August 12, 2016. Accessed on: August 12, 2016.

 

 

Related Stories:

 

 

Michael O’Riordan is the Associate Managing Editor for TCTMD and a Senior Journalist. He completed his undergraduate degrees at Queen’s…

Read Full Bio

Comments