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Forest and Cypress Announce FDA Approval of Savella(TM) for the Management of Fibromyalgia
Date:1/14/2009

product of a unique clinical development program, one that considered a patient to be a responder to therapy only if they demonstrated concurrent clinically significant changes in multiple aspects of their fibromyalgia, including pain, patient global assessment and physical function. Savella is the only product approved for the management of fibromyalgia that used this complete responder analysis as its primary endpoint," said Jay D. Kranzler, MD, PhD, Chairman and CEO of Cypress Bioscience.

Howard Solomon, Chairman and Chief Executive Officer of Forest said, "We and our partner Cypress Bioscience are very pleased to receive marketing approval for Savella, following a first-cycle review, from the FDA. Fibromyalgia is a chronic and often debilitating condition with a significant need for new therapies. Savella is a valuable new treatment for patients afflicted with fibromyalgia. Its effectiveness was evaluated based upon the multiple symptoms included in the responder analysis."

"This approval is crucial for Pierre Fabre Laboratories as milnacipran is one of the flagship products of our portfolio and represents another product of Pierre Fabre research registered in the United States," said Jean-Pierre Garnier, Chief Executive Officer of Pierre Fabre SA.

Although the exact mechanism by which Savella improves the symptoms of fibromyalgia is unknown, some researchers believe that abnormalities in certain brain neurotransmitters may be central to fibromyalgia. Savella blocks the reuptake of both norepinephrine and serotonin, with greater selectivity for the inhibition of norepinephrine reuptake in vitro. This may be the mechanism by which Savella acts to improve the symptoms of fibromyalgia.

Data Highlights

The clinical development program for Savella was unique in its use of a composite responder analysis as the primary endpoint. This endpoint required individual patients to demonstrate c
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SOURCE Forest Laboratories, Inc.; Cypress Bioscience, Inc.
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