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Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce,Positive Results of Phase III Study for Milnacipran as a Treatment,for Fibromyalgia Syndrome

ting pain as measured by the Patient Experience Diary (PED), the overall impression of patient well being as measured by the Patient Global Impression of Change (PGIC) and an analysis of physical function as measured by the SF-36 Physical Component Summary for patients receiving either dose of milnacipran compared to placebo. The difference between active doses and placebo was assessed by a responder analysis with a responder defined as a subject meeting the criteria for the treatment of pain associated with fibromyalgia and in addition showing improvement in physical function as assessed by the SF-36 Physical Component Summary.

Treatment of Pain Associated with Fibromyalgia

This endpoint showed statistically significant improvement for milnacipran compared to placebo for patients receiving 200 mg per day of milnacipran (p=0.004) and for patients receiving 100 mg per day of milnacipran (p=0.025).

These results were analyzed using the Baseline Observation Carried Forward (BOCF) analysis, as agreed to with the U.S. Food and Drug Administration (FDA).

Treatment of Fibromyalgia Syndrome

This endpoint also showed statistically significant improvement for milnacipran compared to placebo for both the 200mg per day dose (p=0.015) and 100mg per day dose (p=0.011) using the Baseline Observation Carried Forward (BOCF) analysis. Results for both endpoints listed above were also statistically significant when analyzed using a Last Observation Carried Forward (LOCF) method.

Component Assessments

In addition, when analyzed according to the pre-specified analysis plan both the pain and the PGIC components of the composite endpoint individually achieved statistical significance in favor of milnacipran at both doses and the SF-36 Physical Component Summary met statistical significance at one dose.

Tolerability

Milnacipran was generally well tolerated, with the majority of patient withdrawals occurring early in the trial.
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