Janssen lifts voluntary hold on FAAH Phase 2 study
The suspension took place after the company became aware of complications in France during January 2016 when another company was conducting a Phase 1 safety study for a drug in the same class.
Janssen took great care and worked alongside of experts and authorities in the areas health and drug safety to ensure that their investigational drug was fully safe.
On March 3, Janssen had not been given any indication of negative results from their Phase 2 studies with the FAAH inhibitor in either patients suffering from social anxiety disorder or major depressive disorder with anxious distress.
Janssen has deduced that since its Phase 2 drug had not been linked to any of the adverse effects, the incidents that took place in France were correlated to the other company's chemical makeup, selectivity, potency, pharmacokinetics, clinical experience and dosing.