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FMS is a chronic pain syndrome that is estimated to affect 2-4% of the general population. The symptoms of FMS can be debilitating, and are characterized by chronic and widespread pain throughout the body, often accompanied by severe fatigue and poor sleep. Treatment options are limited as there are no drugs specifically approved by the U.S. Food and Drug Administration for the treatment of FMS.

There were a total of 125 patients enrolled in the double blind, placebo-controlled, flexible dose escalation mono-therapy trial. Patients were randomized to receive placebo or milnacipran (either once or twice per day) for four weeks of dose escalation, followed by eight weeks of constant dose. The study evaluated the efficacy and safety of milnacipran for the treatment of pain and associated symptoms such as fatigue, depressed mood and sleep.

Patients were asked to characterize their pain, fatigue, sleep quality and related symptoms several times each day on an electronic diary. The Company had reported results from a preliminary analysis of 95 patients from the trial in December 2002. Today’s announcement represents the final results, which include the entire 125 patients.

Milnacipran-treated patients randomized to the twice a day dosing group (BID) showed statistically significant improvements in pain compared to those who received placebo. Seventy percent of all milnacipran-treated patients reported overall improvement, compared to 36 percent in the placebo group (p=0.006). Further, 37 percent of milnacipran BID-treated patients reported at least a 50 percent reduction in pain intensity, compared to 14 percent of patients who received placebo, a difference that was statistically significant (p=0.0395, intent to treat analysis).

In addition, milnacipran-treated patients showed improvements in fatigue and depressed mood on multiple outcome measures.

"FMS is currently an incredibly challenging condition to manage clinically. If further studies confirm these data and this level of improvement in these patients, drugs like milnacipran could dramatically change the way we treat FMS," said Dr. Daniel Clauw, Professor of Medicine, Division of Rheumatology; Director, Center for Advancement of Clinical Research; and Director, Chronic Pain and Fatigue Research Center, The University of Michigan and Chairman of Cypress’ Rheumatology Advisory Board.

“These final results, similar to the preliminary results announced in December, suggest that milnacipran, a novel dual-acting reuptake inhibitor that acts on two key neurotransmitters, norepinephrine and serotonin, which are involved with the central modulation and processing of chronic pain, may have the potential to relieve not only pain but several of the other symptoms associated with FMS, and perhaps other related Functional Somatic Syndromes,” noted Jay D. Kranzler, MD, PhD, Chairman of the Board and Chief Executive Officer of Cypress Bioscience Inc.

Eighty-four percent of all milnacipran patients escalated to the highest dose with no tolerability issues. The most common dose-related side effect reported by patients was nausea, particularly early in the study. Most adverse events were mild to moderate in intensity, and transient in duration. Further details of the data from the trial will be presented at the American Pain Society meeting in March 2003.