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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