FDA Approves Duloxetine for Maintenance Treatment of Generalized Anxiety Disorder
November 30, 2009 — The US Food and Drug Administration (FDA) has approved an expanded indication for duloxetine HCl (Cymbalta delayed-release capsules, Eli Lilly & Company, Inc) for the maintenance treatment of generalized anxiety disorder (GAD). Previously, use of the selective serotonin-norepinephrine reuptake inhibitor was limited to acute therapy.
GAD is a pattern of frequent and constant anxiety, exaggerated worry, and tension that affects approximately 7 million people in the United States. Left untreated, symptoms may progressively worsen with a corresponding negative effect on the patient's ability to function well in work, family, and social situations.
"Since generalized anxiety disorder can be a chronic illness, it is important that doctors and their patients find a treatment option that is effective in both the acute and maintenance phase of treatment," said James M. Martinez, MD, US medical director for Cymbalta, in a company news release. "With this additional approval, Cymbalta offers a new option for the maintenance treatment of this often-debilitating condition."
The FDA's action was based on data from a double-blind study of 429 patients who had responded to 26 weeks of initial treatment with duloxetine at doses ranging from 60 to 120 mg/day. Results showed that patients who continued to receive duloxetine for 26 weeks had a significantly decreased rate of GAD relapse compared with those switched to placebo (15% vs 46.4%).
Treatment-emergent adverse events most commonly reported in the study included nausea, headache, dry mouth, diarrhea, dizziness, constipation, fatigue, and increased sweating.
Duloxetine extended-release capsules previously were approved for the acute and maintenance treatment of major depressive disorder and the management of diabetic peripheral neuropathic pain and fibromyalgia.