Health

FDA approves first Huntington's drug

NEWS IN BRIEF — Posted Sept. 8, 2008

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The Food and Drug Administration gave approval in August for the first medication that treats the symptoms of Huntington's disease.

"For the first time, there is a treatment that can help patients with this disease gain some quality of life," said Timothy Coté, MD, MPH, director of the agency's Office of Orphan Products Development.

Tetrabenazine decreases the amount of dopamine available in the brain and provides some relief from chorea, the jerky and involuntary movements that are a significant feature of this uncommon genetic disorder. It's manufactured by Prestwick Pharmaceuticals Inc. and distributed as Xenazine.

The most common side effects that have been reported include insomnia, depression, drowsiness, restlessness and nausea. Also possible are suicidal thoughts and actions, and the agency has attached a "Risk Evaluation and Mitigation Strategy" to ensure that the drug's benefits outweigh its risks. Clinical trials demonstrated that it could decrease chorea in the short term, but also was associated with slight worsening of mood, cognition, rigidity and functional capacity.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2008/09/08/hlbf0908.htm.

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