Affects serotonin, norepinephrine: FDA approves duloxetine for the treatment of major depressive disorder.(News)

Approval of duloxetine hydrochloride by the Food and Drug Administration offers an additional drug for the treatment of major depressive disorder that affects both serotonin and norepinephrine.

In a statement announcing the approval, Dr. Stephen M. Stahl said duloxetine (Cymbalta), manufactured by Eli Lilly & Co., "offers physicians a new opportunity to help patients with depression, particularly those who experience the common physical symptoms of the disease, such as vague aches and pains."

But duloxetine "is not an analgesic, and it would be wrong to characterize it that way," Dr. Stahl told this newspaper.

Like selective serotonin reuptake inhibitors, duloxetine might take 2-8 weeks to take effect, said Dr. Stahl, who is chairman of the Neuroscience Education Institute, Carlsbad, Calif.; an adjunct professor of psychiatry at the University of California, San Diego; and a consultant to Lilly.

Venlafaxine hydrochloride (Effexor), also a selective serotonin and norepinephrine reuptake inhibitor, was approved in 1993. In addition to depression, venlafaxine, manufactured by Wyeth Pharmaceuticals, is indicated for the treatment of generalized and social anxiety disorders.

To date, no head-to-head trials have been conducted between venlafaxine and duloxetine.

In clinical trials, duloxetine was studied in doses of 40-120 mg, and the recommended daily dose is 60 mg. It was shown to effectively relieve depression as measured by the Hamilton Depression Rating scale. In support of its FDA application, Lilly studied duloxetine treatment in 6,000 adults with major depressive disorder, aged 18-83 years, as part of four randomized, double-blind, placebo-controlled studies, and in a 1-year open label safety study.