FDA approves fibromyalgia drug - developers say
NEW YORK Jan 14 (Reuters) - Forest Laboratories Inc (FRX.N) and Cypress Bioscience Inc CYPB.O said on Wednesday that the U.S. Food and Drug Administration approved their drug Savella for the management of fibromyalgia.
Fibromyalgia is a chronic condition characterized by widespread pain and decreased physical function, afflicting as many as six million people in the United States.
The safety and efficacy of Savella was established in two U.S. pivotal Phase III clinical trials involving over 2,000 patients with fibromyalgia, the companies said.
They expect Savella (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor, to be available in pharmacies by March 2009.
Stock in both companies soared in after-hours trading. Forest was trading at $27.52, after closing the day at $24.23 on the New York Stock Exchange, and Cypress was up to $11.95 from its close of $7.21 on the Nasdaq.
(Reporting by Steve James)
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