Cymbalta approved for maintenance treatment of generalized anxiety disorder (GAD)

The FDA has approved Cymbalta (duloxetine HCl, from Lilly) for the maintenance treatment of generalized anxiety disorder (GAD) in adults. This approval was based on clinical data from a double-blind, placebo-controlled trial. Patients with GAD who initially had responded to treatment with Cymbalta during a 26-week open-label phase were randomly assigned to receive Cymbalta or placebo. Patients taking Cymbalta experienced a statistically significantly longer time to relapse of GAD than those on placebo. The estimated probability of relapse at 26 weeks of maintenance treatment was 15% for Cymbalta versus 46.4% for placebo.

Cymbalta is a serotonin and norepinephrine reuptake inhibitor already indicated for the initial treatment of GAD, for major depressive disorder, and for fibromyalgia.

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