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NEWS about Duloxetine

Posted by ben on May 23, 2002, at 14:37:45

LOS ANGELES, May 22 (Reuters) - An experimental antidepressant reduces symptoms of anxiety in depressed patients, Eli Lilly & Co. (NYSE:LLY - News), which is developing the drug said on Wednesday.

At a meeting of the American Psychiatric Association in Philadelphia, the Indianapolis-based pharmaceutical company also presented trial results for the drug, called duloxetine, showing that it has the same affect on weight gain as placebo.

Lilly said duloxetine, which works by inhibiting the brain's reuptake of messenger chemicals serotonin and norepinephrine, taken once daily at a standard starting dose of 60 milligrams, significantly reduced anxiety symptoms compared to placebo based on a commonly-used scale.

"Because anxiety is common in major depression, any first-line antidepressant must show efficacy in treating anxiety symptoms," said Dr. Michael Detke, a research physician at the company.

Some 60 percent of patients with major depressive disorder report symptoms of anxiety. These patients have a higher risk of recurrence and suicide when compared to patients with only depression.

Lilly, which saw its blockbuster antidepressant Prozac go off-patent last August, filed late last year for U.S. Food and Drug Administration approval of duloxetine and hopes to launch the drug commercially late this year.

The drug is unique because it works to alleviate physical pain -- like backache and headache -- as well as the usual emotional symptoms of depression, Detke said.

In other clinical trials up to 12 weeks long, data showed duloxetine had little effect on body weight, Lilly said.

The company said aggregated data from several clinical trials suggest that patients taking duloxetine did not experience clinically significant weight gain.

Duloxetine-treated patients, in these trials, experienced an average weight loss of 1.11 pounds, while patients on placebo experienced an average weight gain of 0.55 pounds. In a one-year study, the average weight increase for patients on duloxetine was 2.46 pounds.

"That's about what you see in the general population," Detke said.


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poster:ben thread:107418
URL: http://www.dr-bob.org/babble/20020517/msgs/107418.html