Posted by Phillipa on December 1, 2009, at 20:52:46
This must be biased as this med made mine worse even with benzos??? What happened to only up to 60mg being approved for use? Phillipa
om Medscape Medical News > Alerts, Approvals and Safety Changes > FDA Approvals
FDA Approves Duloxetine for Maintenance Treatment of Generalized Anxiety Disorder
Yael Waknine
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.
poster:Phillipa
thread:927754
URL: http://www.dr-bob.org/babble/20091127/msgs/927754.html