FDA Approval of Savella for the Management of Fibromyalgia
On January 14th the Forest and Cypress have announced that the U.S. Food and Drug Administration (FDA) have approved Savella (also known as milnacipran) for the management of fibromyalgia. From the press release:
"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 (U.S.) pharmacies by March 2009."
Dr. Daniel Clauw, Professor of Anesthesiology and Medicine (Rheumatology) at the University of Michigan. said "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. 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 method by which Savella helps fibromyalgia patients is not understood, the belief is that the brains neurotransmitters may be involved. The press release states "Savella blocks the reuptake of both norepinephrine and serotonin, with greater selectivity for the inhibition of norepinephrine reuptake in vitro. This may be the mechanism by which Savella acts to improve the symptoms of fibromyalgia."
You can read the drug information from the FDA here including approval information. The full press release from Forest Laboratories can be found on their website.
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