Following one fatality and four neurological injuries in French clinical study subjects, U.S. Food and Drug Administration (FDA) officials recently teamed up with European counterparts to investigate the circumstances surrounding BIA 10-2474, a drug manufactured in Portugal.
The medication, classified as an investigational new drug (IND), is intended to inhibit fatty acid amide hydrolase (FAAH), an enzyme involved in nervous system function. FAAH inhibitors have been eyed as a potential way to combat certain neurological conditions.
The U.S. itself has not undertaken any clinical studies of the drug. It is collaborating, however, with European authorities to ensure the safety of future study participants, possibly craft regulatory oversight and see to consumer education regarding such medications’ risks and benefits.
Now consulting with the European Medicines Agency (EMA) and the French National Agency for Medicines (ANSM), the FDA is hoping to collect the maximum amount of information surrounding the unfortunate outcomes.
In order to qualify for FDA regulatory approval in the U.S., a significant amount of data must be collected using animals prior to enrolling human volunteers. Regulations surrounding the procedure are strict, stipulating timelines, safety-related data review and screening for possible adverse effects.
The clinical study was conducted by Biotrial, a French clinical research organization, and utilized a product supplied by Bial-Portela & Ca, a pharmaceutical company headquartered in Sao Mamede do Coronado, Portugal.