NEWS - FDA approves Savella (milnacipran) for fibromyalgia

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FDA Approves Milnacipran for Fibromyalgia

January 15, 2009 — Forest Laboratories and Cypress Bioscience

announced January 14 that the Food and Drug Administration (FDA) has

approved milnacipran (Savella), a dual serotonin- and

norepinephrine-reuptake inhibitor (SNRI), for the management of

fibromyalgia.

Efficacy of the drug was established in 2 pivotal US phase 3 trials,

the companies note in a press statement. Treatment with 100-mg/day and

200-mg/day doses demonstrated " statistically significant and

clinically meaningful " concurrent improvements in pain, patient global

assessment, and physical function, the statement adds.

The companies expect the drug to be available in pharmacies by March 2009.

Fibromyalgia, characterized by widespread pain and decreased physical

function, affects as many as 6 million people in the United States,

according to estimates from the American College of Rheumatology, the

statement notes.

Although the exact mechanism of the benefit of milnacipran in this

setting is not known, " some researchers believe that abnormalities in

certain brain neurotransmitters may be central to fibromyalgia, " the

release states. Milnacipran blocks reuptake of serotonin and

norepinephrine, with greater selectivity for norepinephrine in vitro.

" This may be the mechanism by which [milnacipran] acts to improve the

symptoms of fibromyalgia. "

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Read the full article here:

http://www.medscape.com/viewarticle/586898

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