Forest, Cypress to run third phase 3 trial of milnacipran for fibromyalgia

Erie, Pa., Jan. 5 - Forest Laboratories, Inc. and Cypress Bioscience, Inc. plan a third randomized, double-blind, placebo-controlled phase 3 study to evaluate milnacipran as a treatment for fibromyalgia. The study is slated for the first quarter of this year.

The results from the first phase 3 study supported milnacipran's effect in the treatment of fibromyalgia patients. Based on these results, modifications were made to the ongoing second phase 3 study, including expanding the study to 1,200 patients from 800. Initial results from the second phase 3 study are expected to be announced in mid 2007, at the earliest.

Milnacipran is the first of a new class of agents known as norepinephrine serotonin reuptake inhibitors, or NSRIs. These agents are designed to preferentially inhibit the reuptake of norepinephrine over serotonin, two neurotransmitters that help regulate pain and mood. Milnacipran has been approved for the treatment of non-pain indications in 32 countries and has been used by more than 3 million patients during more than six years of commercial availability outside the United States. Forest Laboratories and Cypress Biosciences, its licensor, are jointly developing milnacipran for the treatment of fibromyalgia in the U.S. market.

Fibromyalgia is a chronic, debilitating condition characterized by widespread pain and stiffness throughout the body. Six million to 12 million people in the United States are affected by fibromyalgia, according to a news release, and there are no treatments specifically approved for fibromyalgia in the United States or elsewhere.

Cypress Bioscience, based in San Diego, brings to market products that improve the treatment of Functional Somatic Syndromes, including fibromyalgia syndrome, and other central nervous system conditions, such as Obstructive Sleep Apnea.

New York-based Forest Laboratories' products include: Lexapro, an SSRI antidepressant for the treatment of major depressive disorder and generalized anxiety disorder; Namenda for the treatment of Alzheimer's disease; Benicar and Benicar HCT for the treatment of hypertension; Campral indicated for the maintenance of abstinence from alcohol; and Combunox for the short-term management of acute, moderate to severe pain.

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