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Milnacipran Demonstrated Significant Improvement in Pain and the Core Symptoms of Fibromyalgia Syndrome, Data Show
Date:11/8/2007

NEW YORK, Nov. 8 /PRNewswire/ -- Total daily dosages of milnacipran 100 mg and 200 mg demonstrated statistically significant and clinically meaningful improvements in both pain and other core symptoms associated with fibromyalgia syndrome (FMS), according to Phase III data presented this week at the 2007 American College of Rheumatology meeting in Boston, MA. The therapeutic effects of milnacipran among responders in a six-month study were sustained for up to one year in a double-blind extension trial.

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Although widespread chronic pain is the defining characteristic of FMS, it typically occurs as part of a broader spectrum of symptoms, including fatigue, cognitive dysfunction, and reduced physical function. Milnacipran is the first treatment studied for fibromyalgia whose effectiveness has been evaluated utilizing a composite responder approach which requires, on a patient-by- patient basis, concurrent improvements across multiple FMS domains. As such, composite responder analyses represent a more stringent assessment of therapeutic effect than the evaluation of individual symptoms.

To be considered a responder for the composite "pain of fibromyalgia" endpoint, each patient had to demonstrate concurrent and clinically meaningful improvements in two validated measures: pain and global impression of disease status. In addition to meeting those criteria, responders for the composite "treatment of the fibromyalgia syndrome" endpoint also had to demonstrate improvement in a third validated measure: physical function. The results of two Phase III trials showed that milnacipran demonstrated improvement compared to placebo in treating both the pain of fibromyalgia, as well as the broader syndrome of fibromyalgia. Furthermore, data from a six-month extension study showed that the therapeutic effects of mi
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SOURCE Forest Laboratories, Inc. and Cypress Bioscience, Inc.
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