FDA finds drug class at centre of French trial tragedy do not pose similar safety risks
pharmafile | August 15, 2016 | News story | Manufacturing and Production, Research and Development | Bial, Biotrial, FDA, faah, rennes
The US Food and Drug Administration (FDA) has issued a statement following the results of their investigation into the recent Rennes clinical trial tragedy which indicates that other FAAH inhibitors do not pose similar safety risks to BIA 10-2474.
One man was killed, and five others injured, during a Phase I clinical trial in the French city of Rennes in January. Clinical trial company Biotrial was conducting the study on behalf of Bial, a Portuguese pharmaceutical manufacturer. In a subsequent investigation, French authorities blamed both for their role in the tragedy indicating that it took far too long for the adverse events to be reported to the relevant bodies.
A subsequent FDA investigation into BIA 10-2474, the fatty acid amide hydrolase inhibitor at the centre of the study, looked at the drug and the potential adverse effects that similar drugs currently under investigation could have in the US.
The agency finds: “Based on the available information, BIA 10-2474 exhibits a unique toxicity that does not extend to other drugs in the class, called fatty acid amide hydrolase (FAAH) inhibitors.”
The regulator indicates that it will work with trial sponsors going forward to work on the safest method to conduct studies using this class of drugs.
In a report by French authorities, the drug was believed to “appear to be a lot less specific to FAAH than its predecessors, making binding to other cerebral enzymes plausible.”
Sean Murray
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