FDA Backs Savella for Fibromyalgia | Arthritis Information

 

Cypress Bioscience's newly approved fibromyalgia drug Savella (milnacipran) is the first to score the regulatory hat-trick of pain relief, improved ability to function, and improved sense of well-being. Cypress partnered with Forest Laboratories, Inc. to develop the drug.

Savella is a selective serotonin and norepinephrine dual reuptake inhibitor. The safety and efficacy of Savella was established in two US pivotal phase III clinical trials involving over 2,000 patients with fibromyalgia. The studies showed that 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. The companies expect Savella to be available in pharmacies by March 2009.

“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.”

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