Forest, Cypress say Savella met goal in study

Forest Labs, Cypress say Savella helped symptoms of fibromyalgia in late stage trial

• On 7:33 am EDT, Monday October 19, 2009

NEW YORK (AP) -- Forest Laboratories Inc. and Cypress Biosciences Inc. said Monday that a late stage clinical trial shows their fibromyalgia drug Savella is effective at managing symptoms of the chronic condition that causes pain, depression and fatigue.

The companies said patients who took Savella had less pain, and better overall health and physical function, than patients who took a placebo.

There is no known cause or cure for the condition, and the companies say there are about 6 million patients in the U.S.

The companies received marketing approval for Savella in January and began selling the drug in April.

In the study, 1,025 patients were assigned to receive Savella or a placebo. They were treated with a full dose for three months. Forest and Cypress said the subjects who took Savella were more likely to have at least a 30 percent reduction in pain, and said they were "much improved" or "very much improved."

Patients took 100 milligrams of Savella per day, which is the same dose that the FDA approved. New York-based Forest and San Diego-based Cypress said they will present full results from the study Tuesday at a meeting of the American College of Rheumatology in Philadelphia.

The most common side effects in the study were nausea, headache, constipation, hot flush, dizziness, insomnia, excessive sweating, palpitations, fatigue, rapid heartbeat, and high blood pressure.

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