The US Food and Drug Administration (FDA) approved Savella™, a selective serotonin and norepinephrine dual reuptake inhibitor, for the management of fibromyalgia, a condition that can cause sleep disturbance. The drug was developed by Forest Laboratories Inc and Cypress Bioscience Inc.
"Fibromyalgia is a complicated chronic pain condition, so it is important that physicians and patients have access to treatments that have been shown to help manage the symptoms that define the experience of fibromyalgia," said Dr. Daniel Clauw, Professor of Anesthesiology and Medicine (Rheumatology) at the University of Michigan. "The introduction of Savella is important because it is the first drug approved to treat the symptoms of fibromyalgia using a composite responder analysis."
The safety and efficacy of Savella were established in two US pivotal phase 3 clinical trials involving more than 2,000 patients with fibromyalgia. Savella doses of 100 mg/day and 200 mg/day demonstrated statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function. Savella is expected to be available in pharmacies by March 2009.
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