FDAnews Drug Daily Bulletin


April 4, 2006

Eli Lilly's antidepressant drug Cymbalta significantly reduces the core symptoms of generalized anxiety disorder, according to a recent clinical study.

According to the nine-week study, Cymbalta (duloxetine HCl) improved core anxiety symptoms -- such as moodiness, fear and tension -- by 51 percent in patients taking a 60-mg daily dose and by 50 percent in patients taking a 120-mg daily dose, compared to an improvement of 32 percent in patients taking a placebo, Lilly said recently. The study involved roughly 500 patients.

In addition, Cymbalta significantly reduced overall pain by 41 percent and 37 percent in the 60- and 120-mg doses respectively, compared to 16 percent in patients taking the placebo.

Cymbalta is approved in the U.S. for treating adults with major depressive disorder and for those experiencing diabetic peripheral neuropathic pain.

"We are encouraged by these results that suggest Cymbalta may address a broad range of core anxiety symptoms and the associated physical symptoms that are often reported in patients with generalized anxiety disorder," said James Russell, a medical adviser with Eli Lilly.