Duloxetine Gains FDA Approval for Major Depression: Trials of 6,000 Adults with Major Depressive Disorder Show SNRI's Efficacy

By Franklin, Deeanna | Clinical Psychiatry News, September 2004 | Go to article overview

Duloxetine Gains FDA Approval for Major Depression: Trials of 6,000 Adults with Major Depressive Disorder Show SNRI's Efficacy


Franklin, Deeanna, Clinical Psychiatry 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, 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 serotonin norepinephrine reuptake inhibitor (SNRI), 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 ("Antidepressant Duloxetine Considered 'Approvable' by FDA," October 2002, p. 17).

David Shaffer, a Lilly spokesperson, noted that the company has been presenting information about depression's "painful physical symptoms and Cymbalta for some time."

"If you look at the DSM-IV, painful physical symptoms are a part of depression, and Cymbalta is approved for the treatment of depression. It's not necessarily in the label in an explicit way. We did have secondary end points in many of our studies about painful physical symptoms," he said.

Two large, double-blind, placebo-controlled trials showed that duloxetine relieved diabetic neuropathic pain, Mr. Shaffer said. Those studies, which did not include depressed patients, show "an independent effect on pain that supports our assertion that the mechanism of action of duloxetine hitting on both serotonin and norepinephrine is believed to explain its effect on the painful physical symptoms of depression, as well as the emotional symptoms of depression. …

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