In a proactive move, Janssen Pharmaceuticals announced on January 17 that they were voluntarily halting clinical trials of the experimental drug JNJ-42165279. According to Forbes, the experimental drug being tested is in a similar class of drugs which recently caused serious injury and at least one death in France. Even though Janssen’s FAAH Inhibitor trial had so far resulted in only mild side effects, the company suspended testing pending further evaluation.
New Drugs Called FAAH Inhibitors
The drug Janssen was testing is classified as an FAAH inhibitor which may be of use in treating patients who have distressing anxiety disorders. The French clinical trial had been testing a different drug called BIA 10-2474 which, although chemically different from JNJ-42165279, is also classified as an FAAH inhibitor.
Five Patients Injured, One Dead by Similar Drug in France
A Portugal-based pharmaceutical company called Bial-Portela was conducting a clinical trial of the FAAH inhibitor BIA 10-2474 in Rennes, France, when the tragedies occurred. Out of 90 study participants, six patients who had participated in the study since July were transferred to the University of Rennes Hospital with “severe neurological injuries” on January 15, according to Forbes. PharmExec reported that the doctor in charge of the Rennes, Dr. Pierre-Gilles Edan, described patients’ brains as “showing cerebral hemorrhage and necrosis,” with some possibly suffering a “handicap that could be irreversible.” One patient subsequently died two days later.
Previous FAAH Inhibitor Trials Had Positive Results
Janssen’s JNJ-42165279 had been shown to be safe in both Phase 1 and Phase 2 of its trial. Additionally, Pfizer Pharmaceuticals had previously tested an FAAH inhibitor of its own, called PF-04457845, which also performed safely in two trial phases.
Scientists Unclear on the Cause of the Tragedy
Since thus far FAAH inhibitors had been shown in studies to have only mild unintended effects, there is uncertainty among research scientists about what was to blame for the Bial-Portela test’s terrible outcome. Although there are unknowns about this class of drugs, some scientists are questioning everything about the design of the study, including a possible dosing accident.
Investigation by French Authorities
France’s drug regulation agency, the Rennes prosecutor’s office, and the Paris prosecutor’s office have opened an investigation, according to the New York Times.
Janssen Pharmaceuticals is an R&D arm of Johnson & Johnson company.
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