Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative,...
By Jeannie Baumann
Jan. 22 — A pharmaceutical segment of Johnson & Johnson has suspended two clinical trials following news in France of a patient death during tests of another drug in the same class.
Janssen Research & Development LLC said the decision to stop a dosing study of an experimental treatment for mood disorders was entirely voluntary.
“At Janssen, the safety and well-being of patients who participate in our clinical trials are most important,” the company said in a Jan. 17 statement.
The announcement by Janssen came days after early phase testing of another anxiety drug in Rennes, France, was linked to the death of one research subject and the hospitalization of five others (10 LSLR 02, 1/22/16). French health ministers said they have opened a preliminary investigation into the study.
Janssen wasn't involved in the France-based study that led to the serious events as they are separate experimental drugs, but both drugs involved inhibiting the same enzyme, called fatty acid amide hydrolase.
The clinical trial in France was being conducted by the Rennes-based contract research laboratory Biotrial for the Portuguese laboratory Bial, which owns the molecule. Bial's experimental drug was also at an earlier, phase I stage of drug development compared to the phase II clinical trials being suspended by Janssen.
Janssen said the suspension was a precautionary measure, even though it hasn't received any reports of serious adverse events in patients with social anxiety disorder and major depressive disorder with anxious distress, either in the phase II trials or in earlier, phase I safety studies of the drug.
“We have informed health authorities, research sites, and study investigators about the change in status with these studies and instructed investigators to inform study patients as soon as possible,” the Janssen statement said.
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