Milnacipran Clinical Study Demonstrates Effective Treatment of Fibromyalgia Pain is Distinct from Treatment of Mood

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Cypress Bioscience Inc. Announces Milnacipran Clinical Study Results Demonstrating That Effective Treatment of Fibromylagia-Related Pain is Distinct from the Treatment of Mood

SAN DIEGO–(BUSINESS WIRE)–Dec. 11, 2003–Cypress Bioscience Inc. (NASDAQ:CYPB) announced data from its Phase II Fibromyalgia Syndrome (FMS) study demonstrating that treatment with milnacipran was equally effective in reducing pain for both depressed and non-depressed patients. However, the response rate in patients treated with placebo was considerably lower in non-depressed patients than in those patients who met criteria for major depression at the time of entry into the trial.

These data indicate that the therapeutic benefits of milnacipran observed in the study are a result of its analgesic (pain elimination) properties, rather than secondary to its ability to improve mood. Milnacipran is currently being evaluated in a Phase III program for the treatment of FMS, a complex widespread pain syndrome that affects an estimated 5 million to 11 million Americans.

Milnacipran is a novel dual-acting agent that acts on two key neurotransmitters in the human body, norepinephrine and serotonin, which are involved with the central modulation and processing of chronic pain. Previously announced data from the Phase II study provides evidence that milnacipran may be an effective treatment for the pain and other symptoms associated with FMS such as fatigue, sleep disturbances, and depression.

Milnacipran is approved for non-pain indications in 22 countries, and has a well-established safety profile from its use by over 2,000,000 patients during more than six years of commercial availability in Europe, South America, and Asia.

“The patients in the Phase II study who were treated with milnacipran exhibited superior pain relief compared to the placebo-treated patients,” noted Jay D. Kranzler, M.D., Ph.D., chairman of the board and chief executive officer of Cypress. “The fact that milnacipran worked equally well for both non-depressed and depressed patients, whereas the non-depressed patients had a lower placebo response rate than the depressed group, is important to our understanding of FMS.

It suggests that the pain experienced by these patients is not directly related to their mood. The effective treatment of FMS-related pain is therefore distinct from the treatment of the patients’ depression.”

The Phase II study was a 12-week, randomized, double-blind, placebo-controlled trial that enrolled 125 patients at several medical centers in the United States. Participants used an electronic diary to record pain, fatigue, sleep, and quality of life information frequently, on an out-patient basis. The patients’ self-reporting of pain via the electronic diary was supplemented with traditional pain and quality of life inventories during monthly clinic visits. The analgesic effect of milnacipran appeared to be independent of the patients’ depression status at baseline, as indicated by the similarity of pain scores between depressed and non-depressed patients.

There is no U.S. Food and Drug Administration (FDA) approved product for treating FMS, which affects 2-4% of the U.S. population, and is the second most commonly diagnosed condition in rheumatology clinics in the United States after osteoarthritis. Cypress’ current clinical program constitutes the first Phase III studies ever conducted in the U.S. to assess a potential treatment for these patients. The company worked closely with FDA to agree upon a Phase III program that Cypress and the FDA mutually believe will be acceptable to support a New Drug Application for a Fibromyalgia indication.

About Cypress Bioscience Inc.

Cypress is committed to be the innovator and commercial leader in providing products for the treatment of patients with Functional Somatic Syndromes, such as Fibromyalgia Syndrome, or FMS, and other related chronic pain and central nervous system disorders. In August 2001, Cypress licensed from Pierre Fabre Medicament its first product for clinical development, milnacipran. In May 2003, Cypress restated its license agreement with Pierre Fabre. The restated license agreement provides Cypress with an exclusive license to develop and sell any products with the compound milnacipran as an active ingredient for any indication in the United States and Canada. Milnacipran, the first of a new class of agents known as NSRIs, or Norepinephrine Serotonin Reuptake Inhibitors, shares a pharmacological profile with the tricyclic antidepressants (TCAs), considered the most effective drugs for treatment of FMS, while appearing to lack the side effects associated with the latter. In October 2003, Cypress began initiating its Phase III clinical trials for the use of milnacipran as a potential treatment for FMS.

For more information about Cypress, visit the company’s Web site at www.cypressbio.com.

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