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news.Forest Laboratories and Cypress Bioscience are to initiate a third pivotal phase III study evaluating the drug milnacipran as a treatment for fibromyalgia, a debilitating condition characterized by widespread pain and stiffness throughout the body.
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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.
The pain and stiffness that characterize fibromyalgia (FMS) are 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 US. Despite this prevalence there are no treatments specifically approved for FMS in the US or elsewhere.