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Neuroleptic is first drug approved for relief of Huntington's chorea.

The Food and Drug Administration has approved tetrabenazine for treating chorea in patients with Huntington's disease.

Tetrabenazine (Xenazine), the first treatment of any kind to be approved in the United States for the disease, also is the first drug to be approved by the agency for the treatment of chorea. The FDA designated the medication as an orphan drug because it is intended to treat less than 200,000 people in the United States. Huntington's disease affects about 30,000 people in the United States.

In December 2007, all 12 members of the Food and Drug 'Administration's Peripheral and Central Nervous System Drugs Advisory Committee agreed that available data from a randomized, placebo-controlled study of 84 ambulatory patients with Huntington's disease supported the drug's approval. Patients treated with tetrabenazine had reduced chorea; secondary outcomes of function and cognition did not improve.

Findings from other clinical trials showed that patients treated with tetrabenazine have slight worsening in mood, cognition, rigidity, and functional capacity. FDA reviewers initially worried that the drug's effects might be indistinguishable from progression of the disease, but advisory board members felt that the concerns did not warrant delayed approval of the drug.

The approval comes with a required Risk Evaluation and Mitigation Strategy) to ensure that the benefits of the drug outweigh its risks, particularly the risks of depression and suicidal thoughts and actions.

Tetrabenazine decreases the jerky, involuntary movements of chorea in Huntington's disease by reversibly inhibiting vesicular monoamine transporter 2, depleting monoamines presynaptically and depleting dopamine preferentially over norepinephrine and/or 5-hydroxytryptamine, according to its manufacturer, Prestwick Pharmaceuticals Inc.

The drug, used for more than 30 years in the United Kingdom for treating organic movement disorders and tardive dyskinesia, was approved for Huntington's chorea in France in 2005 and in the Netherlands and Germany in 2007. Since 1979, Dr. Joseph Jankovic of Baylor College of Medicine, Houston, has used it on a compassionate-use basis for patients with Huntington's chorea and other movement disorders.

BY JEFF EVANS Senior Writer
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Title Annotation:NEWS FROM THE FDA
Author:Evans, Jeff
Publication:Internal Medicine News
Geographic Code:1USA
Date:Sep 15, 2008
Words:332
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