Tuesday, August 21, 2007

Lilly seeks approval for Cymbalta in fibromyalgia

PR Newswire

BOSTON, Aug 21 - Eli Lilly and Co. said on Tuesday it has filed for U.S. approval to sell its antidepressant Cymbalta as a treatment for the pain condition fibromyalgia.

The company said data shows that patients with and without depression who took Cymbalta showed greater reduction in pain than those who took a placebo.

Fibromyalgia is estimated to affect 2 percent to 4 percent of the U.S. population. It is characterized by widespread pain and fatigue, sometimes to a disabling degree.

Cymbalta is approved in the United States for the treatment of major depression, nerve pain associated with diabetes, and generalized anxiety.

INDIANAPOLIS, Aug. 21 PRNewswire-FirstCall -- New data suggest that patients with fibromyalgia treated with 60mg or 120mg of Cymbalta(R) (duloxetine HCl) experienced greater reduction in pain severity beginning one week after starting duloxetine than those taking placebo (sugar pill), as measured by the Brief Pain Inventory Average Pain Score (BPI).

The study, which included patients with and without depression, also showed greater improvements in patients taking duloxetine than in those taking placebo in scores on the Patient's Global Impression of Improvement questionnaire (PGI- I), which measures how the patient has felt overall since beginning to take the medication. The data were presented today at the 2007 Congress of the International MYOPAIN Society in Washington, D.C.

At three months, patients treated with 60mg per day or 120mg per day of duloxetine showed significantly greater reduction in pain and improvement in PGI-I scores compared with patients taking placebo. At three months, more patients treated with either 60mg or 120mg of duloxetine showed significantly greater reduction in pain as measured by a 30 percent improvement in baseline BPI scores (50.7 percent and 52.1 percent, respectively) compared with patients taking placebo (36 percent).

"Fibromyalgia is a chronic illness, characterized by widespread pain, tenderness and fatigue. It can also affect the patient's overall emotional health and well-being," said I. Jon Russell, M.D., Ph.D., associate professor of medicine at the University of Texas Health Science Center in San Antonio. "Between 34 percent(1) and 62 percent(2) of those living with fibromyalgia will experience depression at some point in their lives. In this study, which included patients with and without depression, duloxetine reduced the pain associated with fibromyalgia."


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