Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Positive Results of Phase III Study of Milnacipran for the Management of Fi...( NEW YORK and SAN DIEGO Dec. 8 2008 /-...),Health

NEW YORK and SAN DIEGO, Dec. 8, 2008 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB) today announced positive top-line results from a 1,025 patient, multicenter, double-blind, placebo-controlled phase III study of milnacipran for the management of fibromyalgia. These results, which confirm the findings from the two previous phase III trials, showed that milnacipran demonstrated a highly statistically significant difference to placebo in responder analyses based on a concurrent and clinically meaningful improvement in pain, patient global impression of change, and physical functioning. Comprehensive analyses of the study data will be completed in the coming weeks, and it is anticipated that further results will be presented during 2009.

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Study Background

In this study, designated MLN-MD-03, patients with an established history of fibromyalgia were enrolled at 75 centers in North America and randomized to receive a daily dose of 100 mg of milnacipran (n=516) or placebo (n=509). The design of the double-blind study included a 4 to 6-week dose escalation phase, a 12-week stable-dose treatment phase, and a 2-week discontinuation phase. The primary efficacy endpoints were the proportion of subjects meeting criteria as composite responders based on one of two definitions. In the first co-primary analysis, a patient had to demonstrate simultaneous improvements on both their daily pain ratings (visual analog scale) and on an overall measure of how their fibromyalgia condition had been since the start of the stu
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