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

g Study FMS-031 also met the composite syndrome responder criteria

at three months (33% and 33% for the milnacipran 100 mg and 200 mg

groups, respectively) compared to patients treated with placebo (17%).

Statistically significant differences were also observed at the six-

month visit: 33% and 32% of patients met responder criteria for the

milnacipran 100 mg and 200 mg groups, respectively, compared to 19% of

patients in the placebo group.

Composite responder rates for fibromyalgia pain (pain and PGIC)

-- A statistically significant number of patients treated with milnacipran

during Study MLN-MD-02 met the composite pain responder criteria (39%

and 46% in the milnacipran 100 mg and 200 mg groups, respectively)

compared to patients treated with placebo (25%).

-- A statistically significant number of patients treated with milnacipran

during Study FMS-031 also met the composite pain responder criteria at

three months (45% and 45% in the milnacipran 100 mg and 200 mg groups,

respectively) compared to patients treated with placebo (27%).

Statistically significant differences were also observed at the six-

month visit: 44% and 45% of patients met the composite pain responder

criteria in the milnacipran 100 mg and 200 mg groups, respectively,

compared to 28% of patients in placebo group.

Tolerability

Milnacipran was generally well-tolerated, with the majority of adverse events (AEs) reported being mild to moderate in nature.

-- The most common treatment emergent AEs during the placebo-controlled

clinical trials included nausea (37% vs. 20% placebo), headache (18%

vs. 14% placebo), constipation (16% vs. 4% placebo), hot flushes (12%

vs. 2% placebo), hyperhidrosis (9% vs. 2 % placebo), vomiting (7% vs.

2%), palpitations (7% vs. 2%), heart rate increase (6% vs. 1
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SOURCE Forest Laboratories, Inc. and Cypress Bioscience, Inc.
Copyright©2007 PR Newswire.
All rights reserved

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