SAN DIEGO--(BUSINESS WIRE)--May 29, 2003--Cypress Bioscience, Inc. (Nasdaq:CYPB - News) announced today that clinical results with its lead product, milnacipran, appear to demonstrate distinct mechanisms for the agent's effects on pain and mood in patients with Fibromyalgia Syndrome (FMS) as presented in a poster presentation by R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Cypress Bioscience, Inc. The poster, entitled "Development of Milnacipran, A Dual Reuptake Inhibitor for the Treatment of Chronic Pain Associated with Fibromyalgia," is being presented today at the annual New Clinical Drug Evaluation Unit (NCDEU) meeting, sponsored by the National Institutes of Mental Health (NIMH) in Boca Raton, Florida. In the study, twice-daily dosing of milnacipran was associated with statistically significant improvements in multiple measures of clinical pain. Other symptoms, including fatigue, mood and patient global improvement reports, were significantly improved in both the once-daily and twice-daily dosing groups, and achieved statistical significance on many of these secondary measures. These findings suggest different therapeutic mechanisms may be operative within different symptom domains of FMS. Milnacipran is a first-in-class Norepinephrine Serotonin Reuptake Inhibitor (NSRI) in late-stage clinical development for the treatment of FMS. Pharmacologically, this agent is differentiated from the Selective Serotonin Reuptake Inhibitors (SSRIs), as well as from the Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), by its preferential blockade of norepinephrine (NE) reuptake over serotonin (5-HT) reuptake. Milnacipran's NE/5-HT profile most closely mimics that of the tricyclic antidepressants (TCAs), a class of compounds with demonstrated effectiveness in FMS. One of milnacipran's potential benefits is that it lacks the other drug characteristics that underlie the TCAs' side effects and can limit their tolerability and usage. The Phase II clinical trial results presented at NCDEU demonstrate the safety and efficacy of milnacipran in treating patients with FMS. A total of 125 patients were enrolled in the trial and were randomized to receive either placebo or milnacipran. Milnacipran was dosed either once or twice a 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, quality of life and ability to sleep. A Phase III clinical program is currently being planned and is expected to commence before the end of the year.