NEW YORK, May 22, 2007 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. and Cypress Bioscience, Inc. today announced that preliminary top-line results from a 1,196 patient randomized, three month, double-blind, placebo-controlled pivotal Phase III study demonstrate statistically significant therapeutic effects of milnacipran as a treatment of fibromyalgia syndrome. At this time the companies have only been able to review initial top-line results and further analyses will be completed in the coming weeks to examine the results in greater detail.
Preliminary Study Results
In the study, patients were randomized to receive either 200mg per day of milnacipran (n=396), 100mg per day of milnacipran (n=399) or placebo (n=401). The primary pre-defined endpoints of this trial were composite responder assessments to evaluate either the treatment of the pain associated with fibromyalgia syndrome or the overall treatment of fibromyalgia syndrome. This composite responder analysis approach, which requires a clinically meaningful improvement in multiple domains, captures in one endpoint improvement in numerous symptoms which comprise this syndrome.
The treatment of pain associated with fibromyalgia is assessed by evaluating pain as measured by the Patient Experience Diary (PED), and the overall impression of patient well being as measured by the Patient Global Impression of Change (PGIC) 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 experiencing both a 30% or greater reduction in pain compared to baseline as measured by a visual analog scale (VAS) and a self assessment of his or her condition by the patient of either "much" or "very much" improved compared to baseline.
The broader evaluation of treatment of fibromyalgia syndrome is
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