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

re assessed for all patients at both the three- and six-month visits.

Patients who completed the full six-months of treatment in Study FMS-031 were eligible to enroll in a multi-center, dose-blinded, extension study designed to evaluate durability of response up to one year. A total of 449 patients were either maintained at 200 mg/day (n=209) or re-randomized to 100 mg/day (n=48) or 200 mg/day (n=192) for an additional six months. Efficacy assessments included change in pain, as measured using a paper visual analog scale, and multidimensional symptomatic improvements, as measured using the Fibromyalgia Impact Questionnaire and PGIC.

Data Highlights

Results reported below are based on observed cases, which include only patients who were evaluable at the landmark visit. In study MLN-MD-02, there were 713 evaluable patients for the fibromyalgia syndrome and pain analyses (n=236 for 100 mg, n=215 for 200 mg, and n=262 for placebo).

In study FMS-031, at the three-month visit there were 549 evaluable patients for the syndrome analysis (n=134 for 100 mg, n=259 for 200 mg, and n=156 for placebo), and 553 evaluable patients for the pain analysis (n=135 for 100 mg, n=260 for 200 mg, and n=158 for placebo). At the six-month visit there were 488 evaluable patients for the fibromyalgia syndrome analysis (n=120 for 100 mg, n=229 for 200 mg, and n=139 for placebo), and 491 evaluable patients for the fibromyalgia pain analysis (n=121 for 100 mg, n=230 for 200 mg, and n=140 for placebo).

Composite responder rates for fibromyalgia syndrome (pain, PGIC, and SF-36 PCS)

-- A statistically significant number of patients treated with milnacipran

during Study MLN-MD-02 met the composite syndrome responder criteria

(25% and 26% for the milnacipran 100 mg and 200 mg groups,

respectively) compared to patients treated with placebo (13%).

-- A statistically significant number of patients treated with milnacipran

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SOURCE Forest Laboratories, Inc. and Cypress Bioscience, Inc.
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