(RTTNews) - Saturday, Forest Laboratories Inc. (FRX: News ) and Cypress Bioscience Inc. (CYPB: News ) said the results from a large-scale, Phase III clinical trial of Savella 100 mg/day demonstrated statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment and physical function. The results will be presented on October 20, at the American College of Rheumatology Annual Meeting in Philadelphia.

Savella is a selective serotonin and norepinephrine dual reuptake inhibitor or SNRI that was approved by the U.S. Food and Drug Administration or FDA earlier this year 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 Phase III double-blind, placebo-controlled trial enrolled 1,025 fibromyalgia patients to further evaluate the efficacy and tolerability of Savella 100 mg/day. Patients were randomized to receive Savella 100 mg/day or placebo and underwent four to six weeks of flexible dose escalation, followed by 12 weeks of stable-dose treatment followed by a two-week randomized, double-blind discontinuation phase.
The study showed statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function, among patients receiving Savella treatment of 100 mg/day, as compared to a placebo treatment group, when measured by patient-reported outcomes assessed in composite responder analyses.

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by RTT Staff Writer

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