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

lnacipran were sustained for up to one year of therapy.

"Because patients with fibromyalgia experience a wide array of symptoms that can overlap with other conditions, diagnosis and treatment can be complicated. Currently, many doctors are using multiple medications to treat the various symptoms of fibromyalgia," said Daniel J. Clauw, MD, lead investigator, Chronic Pain and Fatigue Research Center, University of Michigan. "There is a real unmet need for a therapy that not only relieves pain but addresses the functional and physical aspects of the illness that can have a significant impact on a patient's quality of life."

Study Methodology

In two double-blind, placebo-controlled, pivotal Phase III studies (Study MLN-MD-02 and Study FMS-031), the two parallel, primary efficacy assessments consisted of composite responder analyses for the treatment of both fibromyalgia syndrome and the pain of fibromyalgia. Pain composite responders were defined as individuals who achieved both a greater than or equal to 30% reduction in pain compared to baseline as measured by a visual analog scale recorded daily on an electronic patient experience diary, and who rated themselves as "very much improved" or "much improved" on a Patient Global Impression of Change (PGIC) scale. Fibromyalgia syndrome composite responders needed to satisfy the pain composite criteria as well as demonstrate at least a 6-point improvement in their SF-36 physical component summary (SF-36 PCS) score.

In Study MLN-MD-02, 1196 patients were randomized to receive either milnacipran 100 mg/day (n=399), 200 mg/day (n=396) or placebo (n=401) over a three-month period, 67.7% of whom completed the trial.

In Study FMS-031, 888 patients were randomized to receive either milnacipran 100 mg/day (n=224), 200 mg/day (n=441) or placebo (n=223) for six- months, 63.6% of whom completed three-months of treatment, and 57.6% of whom completed the full six-months of double-blind treatment. Results we
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SOURCE Forest Laboratories, Inc. and Cypress Bioscience, Inc.
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