Pharmaceutical Business review

US regulator clears Eli Lilly antidepressant drug

The safety and efficacy of Cymbalta in the treatment of generalized anxiety disorder (GAD) was established in three studies in non-depressed adults with GAD.

In all studies, Cymbalta significantly improved core anxiety symptoms as measured by the Hamilton Anxiety Scale (HAMA), 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, home, and in social situations.

On average, patients treated with Cymbalta for generalized anxiety disorder experienced a 46% improvement in anxiety symptoms compared to 32% for those who took placebo. In addition, patients in these studies experienced a 46% improvement in function compared to 26% for those who took placebo.

In clinical trials, Cymbalta was studied in a dose range of 60-120mg per day. While a 120mg/day dose was shown to be effective, there is no evidence that doses greater than 60mg/day confer additional benefit.

Cymbalta, a member of a class of drugs commonly referred to as serotonin and norepinephrine reuptake inhibitor (SNRI), is already approved for the treatment of major depressive disorder and management of diabetic peripheral neuropathic pain.