Prestwick Pharmaceuticals, Inc., a privately-held pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved XENAZINE® (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.

XENAZINE has been available in a number of countries in Europe for more than 30 years.