US FDA approves Lilly's Cymbalta in GAD

The US Food and Drug Administration has approved US drug major Eli Lilly's antidepressant Cymbalta (duloxetine HCl) for the treatment of generalized anxiety disorder.

The approval is based on the results of three randomized, double-blind, placebo-controlled trials in which the safety and efficacy of duloxetine in the treatment of GAD was studied in more than 800 non-depressed adults. Lilly noted that, in all studies, Cymbalta significantly improved core anxiety symptoms as measured by the Hamilton Anxiety Scale, compared with placebo. In addition, patients on the drug reported improved ability to perform everyday activities at work, home and in social situations.

The serotonin and norepinephrine reuptake inhibitor was approved in Mexico for the treatment of GAD in October 2006. Lilly and Germany-based Boehringer Ingelheim, which is its partner in the development and commercialization of the agent for neuroscience indications in most countries outside the USA and Japan, are evaluating further submissions in other regions, including Europe.