Precautionary Measure Follows Safety Issue with Different Drug in Class
At Janssen, the safety and well-being of patients who participate in our clinical trials are most important.
As a precaution, Janssen is voluntarily suspending dosing in two Phase 2 clinical studies of an experimental medicine -- a FAAH inhibitor -- following reports in France on Friday, January 15, 2016 of serious adverse events in another company's Phase 1 safety study with an experimental drug in this class.
Janssen has not received any reports of serious adverse events in our Phase 2 studies with our FAAH inhibitor in patients with social anxiety disorder and in major depressive disorder with anxious distress, or in earlier, Phase 1 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.
We have asked clinical trial investigators to instruct study patients to speak to their treating physicians about approved, available medications for their study-related medical conditions.
We will reevaluate our decision to suspend dosing in these clinical trials when we have additional information.