Forest Laboratories Inc. and Cypress Bioscience Inc. will initiate a third randomised, double-blind, placebo-controlled pivotal phase III study evaluating milnacipran as a treatment for fibromyalgia (FMS) in the first quarter of 2006.

Based on an analysis of the results from the first phase III study, which was supportive of milnacipran's effect in fibromyalgia patients, certain modifications have been made to the ongoing second phase III study. These modifications include increasing the size of the second study from approximately 800 patients to 1,200 patients. Based on the anticipated time necessary to recruit the additional patients the companies expect to announce initial results from the second phase III study no earlier than mid-calendar 2007, states a company release.

Milnacipran is the first of a new class of agents known as norepinephrine serotonin reuptake inhibitors or NSRIs, which exerts its effect by preferentially inhibiting the reuptake of norepinephrine over serotonin, two neurotransmitters known to play an essential role in regulating pain and mood. It has been approved for the treatment of non-pain indications in 32 countries and has been used safely by more than 3 million patients during more than six years of commercial availability outside the US. Milnacipran is being developed for fibromyalgia in the United States market jointly by Forest and its licensor, Cypress Biosciences, Inc.

FMS is a chronic and debilitating condition characterised by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. According to the American College of Rheumatology, FMS is estimated to affect six to twelve million people in the United States. FMS is most often diagnosed in the primary care setting and in addition is the second most commonly diagnosed condition in rheumatology clinics in the United States after osteoarthritis.

Cypress provides products that improve the treatment of functional somatic syndromes, including fibromyalgia syndrome (FMS), and other central nervous system conditions, such as obstructive sleep apnea (OSA).