Eli Lilly's Cymbalta receives FDA approval

Nov 30 2009

The U.S. Food and Drug Administration (FDA) has approved Cymbalta® (duloxetine HCl) for the maintenance treatment of generalized anxiety disorder (GAD) in adults, announced Eli Lilly and Company (NYSE: LLY).

"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, U.S. Medical Director for Cymbalta. "With this additional approval, Cymbalta offers a new option for the maintenance treatment of this often-debilitating condition."

The efficacy and safety of Cymbalta for the maintenance treatment of GAD were established in a double-blind, placebo-controlled trial. Patients with GAD who initially had responded to treatment with Cymbalta 60-120 mg/day during a 26-week open-label phase were randomly assigned to receive Cymbalta 60-120mg/day (216 patients) or placebo (213 patients). At the end of the trial, patients taking Cymbalta experienced a statistically significantly longer time to relapse of GAD than did patients taking placebo. The estimated probability of relapse at 26 weeks of maintenance treatment was 46.4 percent for placebo and 15 percent for Cymbalta. The most commonly reported treatment-emergent adverse events in patients taking Cymbalta in the open-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 to validate the safety and efficacy profile of the medication in its approved indications," added Martinez.

Cymbalta also is approved for the acute and maintenance treatment of major depressive disorder, the management of diabetic peripheral neuropathic pain and fibromyalgia, and for the acute treatment of generalized anxiety disorder, all in adults.

Generalized anxiety disorder affects nearly 7 million Americans at any given time.(i) While the symptoms of GAD can vary from person to person, they may include excessive worry or anxiety over a period of six months or longer, difficulties controlling worry, irritability, poor concentration, sleep disturbances, fatigue, restlessness and muscle tension.(ii) If left untreated, symptoms may get progressively worse.(iii) Additionally, GAD can have a negative impact on a person's ability to function well in work, family and social situations.(iv)