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Published on 18 August 2008

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FDA approves Huntington’s drug

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A new drug has been approved for use in the US for the treatment of people with Huntington’s disease.

The US Food and Drug Administration (FDA) has approved Xenazine (tetrabenazine) for the treatment of chorea – the jerky, involuntary movement that occurs in people with Huntington’s. Xenazine is the first treatment of any kind approved in the US for any symptom of Huntington’s disease.

The drug can cause serious side-effects including depression and suicidal thoughts, and therefore should not be used in patients who are actively suicidal or in patients with untreated depression.

“Xenazine represents hope for patients and families dealing with this difficult disease,” said Timothy Coté, the director of FDA’s Office of Orphan Products Development. “For the first time, there is a treatment that can help patients with this disease gain some quality of life.”

The effectiveness and safety of Xenazine was established primarily in a randomised, double-blind, placebo-controlled multi-centre clinical trial. Patients treated with Xenazine had a significant improvement in chorea compared with patients treated with placebo.

The most common side-effects reported by patients using Xenazine in clinical trials include insomnia, depression, drowsiness, restlessness and nausea.

Xenazine is manufactured by US firm Prestwick Pharmaceuticals.

Copyright PA Business 2008

US Food and Drug Administration



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