FAAH Inhibitor Trials Could Resume In US Following French Study Disaster Review
Bial-Portela's drug had 'unique toxicity' not found with other compounds in the class, FDA says; findings could allow studies of Janssen's and Pfizer's investigational FAAH inhibitors that have been on hold to proceed.
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The French committee looking into the devastating failure of the Phase I study with Bial's experimental FAAH inhibitor BIA 10-2474 has called for an international debate on whether data from first-in-human trials of new drugs should be made publicly accessible in order to better protect volunteers taking part in such studies1.
US regulators on Jan. 22 said they are conducting a safety probe of fatty acid amide hydrolase (FAAH) inhibitors being developed and studied in the US after one healthy volunteer in a French Phase I trial testing a product in that class died and five other participants experienced severe adverse neurological events.
Janssen has voluntarily suspended dosing in two Phase II studies of its experimental FAAH inhibitor JNJ-42165279; the drug is in the same class as the compound at the heart of the clinical trial tragedy in France.