RESEARCH - Positive results of phase III study of milnacipran for the management of fibromyalgia

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Forest Laboratories, Inc. And Cypress Bioscience, Inc. Announce

Positive Results Of Phase III Study Of Milnacipran For The Management

Of Fibromyalgia

MedicalNewsToday.com

Article Date: 09 Dec 2008 - 0:00 PST

Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc.

(Nasdaq: CYPB) 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.

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 study (Patient Global Impression of Change or

PGIC). In the second co-primary analysis, a patient had to demonstrate

simultaneous improvements on three measures -- pain, PGIC, and

physical functioning (as measured by the SF-36 Physical Component

Summary).

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