Eli Lilly Receives FDA Approval For Cymbalta

Eli Lilly has received FDA approval for Cymbalta (duloxetine HCl) for the maintenance treatment of generalised anxiety disorder (GAD) in adults,

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 60-120mg/day during a 26-week open-label phase were randomly assigned to receive Cymbalta 60-120mg/day (216 patients) or placebo (213 patients).

Reportedly, at the end of the trial, patients taking Cymbalta experienced a statistically 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% for placebo and 15% for Cymbalta.

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

James Martinez, US medical director for Cymbalta, said: “Since generalised 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. With this additional approval, Cymbalta offers a new option for the maintenance treatment of this often-debilitating condition.

“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.”