FDA Approves Cymbalta(R) for Maintenance Treatment of Generalized AnxietyDisorder

The FDA has approved Cymbalta (duloxetine HCl) for themaintenance treatment of generalized anxiety disorder (GAD) in adults, EliLilly and Company announced today. “Since generalized anxiety disorder can be a chronic illness, it isimportant that doctors and their patients find a treatment option that iseffective in both the acute and maintenance phase of treatment,” said James M.Martinez, MD, U.S. Medical Director for Cymbalta. “With this additionalapproval, Cymbalta offers a new option for the maintenance treatment of thisoften-debilitating condition.” The efficacy and safety of Cymbalta for the maintenance treatment of GADwere established in a double-blind, placebo-controlled trial. Patients withGAD who initially had responded to treatment with Cymbalta 60-120 mg/dayduring a 26-week open-label phase were randomly assigned to receive Cymbalta60-120mg/day (216 patients) or placebo (213 patients). At the end of thetrial, patients taking Cymbalta experienced a statistically significantlylonger time to relapse of GAD than did patients taking placebo. The estimatedprobability of relapse at 26 weeks of maintenance treatment was 46.4 percentfor placebo and 15 percent for Cymbalta. The most commonly reportedtreatment-emergent adverse events in patients taking Cymbalta in theopen-label phase of the trial included nausea, headache, dry mouth, diarrhea,dizziness, constipation, fatigue and increased sweating. “This FDA approval, which is the sixth approval for Cymbalta, continues tovalidate the safety and efficacy profile of the medication in its approvedindications,” added Martinez. Cymbalta also is approved for the acute and maintenance treatment of majordepressive disorder, the management of diabetic peripheral neuropathic painand fibromyalgia, and for the acute treatment of generalized anxiety disorder,all in adults.