Forest Labs (FRX) and Cypress Bioscience (CYPB) Announce FDA Approval For Savella
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Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB) announced that Savella, a selective serotonin and norepinephrine dual reuptake inhibitor, was approved by the FDA for the management of fibromyalgia.
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.
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