ELI LILLY'S CYMBALTA APPROVED FOR GENERALIZED ANXIETY DISORDER

Eli Lilly announced that the FDA has approved its antidepressant Cymbalta (duloxetine HCl) for the treatment of generalized anxiety disorder.

The safety and efficacy of Cymbalta in the treatment of generalized anxiety disorder was established in three randomized, double-blind, placebo-controlled studies in more than 800 non-depressed adults with generalized anxiety disorder. In all studies, Cymbalta significantly improved core anxiety symptoms as measured by the Hamilton Anxiety Scale compared with placebo. In addition, Cymbalta patients reported greater improvement in functional impairment associated with the illness, including improved ability to perform everyday activities at work, at home and in social situations.

Cymbalta, a member of a class of drugs commonly referred to as serotonin and norepinephrine reuptake inhibitors (SNRI), has been studied in more than 25,000 patients worldwide and is already approved for the treatment of major depressive disorder and management of diabetic peripheral neuropathic pain.

In clinical trials, on average, patients treated with Cymbalta for generalized anxiety disorder experienced a 46 percent improvement in anxiety symptoms compared with 32 percent of those who took placebo. In addition, patients in these studies experienced a 46 percent improvement in function compared with 26 percent in those who took placebo as measured by the Sheehan Disability Scale.