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XENAZINE(R) (Tetrabenazine) Approved by FDA for Patients with Chorea Associated with Huntington's Disease
Date:8/15/2008

WASHINGTON, Aug. 15 /PRNewswire/ -- Prestwick Pharmaceuticals, Inc., a privately-held pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved XENAZINE(R) (tetrabenazine) for the treatment of chorea associated with Huntington's disease (HD). XENAZINE is the first and only FDA-approved treatment for any symptom of HD and is expected to be available later this year.

"Until today, physicians and patients had no FDA-approved treatments for Huntington's disease," said Fred Marshall, M.D., chief of the geriatric neurology unit at the University of Rochester. "Within a few months, for the first time, physicians will be able to offer these critically-ill patients a safe and effective medication to treat their chorea."

A double-blind, placebo-controlled, Phase 3 study found that XENAZINE significantly reduced patients' chorea burden, improved global outcome scores, and was generally safe and well tolerated. XENAZINE will be marketed under an FDA-approved Risk Evaluation and Mitigation Strategy to decrease the risk of depression and suicidal ideation that may be associated with the drug, and are often pre-existing conditions in Huntington's disease patients.

In December 2007, patients, advocates, and caregivers spoke in favor of approving XENAZINE at a meeting of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee. The committee voted 11-0 to recommend approval of the drug.

"We are pleased that the FDA has approved XENAZINE, the first medication for the Huntington's disease patients and physicians who are in desperate need of a treatment," said George F. Horner, III, president and chief executive officer of Prestwick. "The approval of XENAZINE is a huge advancement for the HD community, and we thank them for their contributions in helping to make this important product available in the United States."

XENAZINE has been available in a number of countries in Europe for mo
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SOURCE Prestwick Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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