Eli Lilly’s Anxiety Drug Wins US Approval

30 November 2009 (Last Updated November 30th, 2009 18:30)

The US Food and Drug Administration (FDA) has approved the use of Eli Lilly's Cymbalta (duloxetine HCl) for the maintenance treatment of generalised anxiety disorder (GAD) in adults. Approval was granted on the basis of clinical trials, which showed that patients taking Cymbalta experienc

The US Food and Drug Administration (FDA) has approved the use of Eli Lilly's Cymbalta (duloxetine HCl) for the maintenance treatment of generalised anxiety disorder (GAD) in adults.

Approval was granted on the basis of clinical trials, which showed that patients taking Cymbalta experienced a statistically significantly longer time to relapse of GAD than did patients taking placebo.

Cymbalta US medical director James M Martinez said that GAD can be a chronic illness, and it is important to find a treatment option that is effective in the acute and maintenance phases of treatment.

"With this additional approval, Cymbalta offers a new option for the maintenance treatment of this often-debilitating condition," Martinez said.

During the double-blind, placebo-controlled trial the estimated probability of relapse at 26 weeks of maintenance treatment was 46.4% for placebo and 15% for Cymbalta.

This is the sixth indication for Cymbalta, which is also is approved for the acute and maintenance treatment of major depressive disorder, the management of diabetic peripheral neuropathic pain and fibromyalgia, and for the acute treatment of GAD in adults.