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New Data Suggest Cymbalta(R) Reduced Pain in Fibromyalgia Patients With and Without Depression

n, fibromyalgia patients often have complaints about cloudy thinking, morning stiffness and overall inability to function in their everyday lives.

Additional Study Highlights

-- At six months, patients taking duloxetine 60mg or 120mg maintained

reduced BPI scores and patients taking 120mg had improved PGI-I scores

compared with those taking placebo.

-- At the end of the six-month trial, more patients treated with both 60mg

or 120mg of duloxetine showed a response to treatment, defined as a 50

percent reduction of baseline BPI scores (32.6 percent and 35.9 percent

of patients, respectively), compared with patients taking placebo (21.6


-- Discontinuation rates over six months were similar among the groups

(45.3 percent and 46.3 percent for duloxetine 60mg and 120mg patients,

compared with 50 percent for placebo).

* Adverse event-related discontinuation was significantly higher in

patients taking 120mg (26.5 percent) but not in the 60mg (15.3

percent) group as compared with placebo (13.2 percent).

Discontinuations due to lack of efficacy were not statistically

different among treatment groups.

* Adverse events were similar to those seen in prior duloxetine

studies. In this study, the most common adverse events (occurred at

a rate of greater than or equal to 5 percent and at least twice the

rate of placebo) included nausea, dry mouth, constipation,

somnolence (sleepiness), fatigue, insomnia, decreased appetite,

hyperhydrosis, cough, tremor, rash and weight increase.

Fibromyalgia sNDA Submitted to FDA

Eli Lilly and Company (NYSE:

SOURCE Eli Lilly and Company

Copyright©2007 PR Newswire.

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