On August 15, 2008 the Food and Drug Administration (FDA) approved the first treatment for HD in the United States when federal regulators cleared Xenazine, a form of tetrabenazine made by Prestwick Pharmaceuticals Inc., for treating chorea. Although Xenazine cannot cure HD and may have harmful side effects, the FDA approval will increase the number of treatment options available to HD patients. To read the FDA news release, click here.
A series of events led up to the approval of Xenazine. The results of the TETRA-HD study were reported in October 2004 and subsequently published in the reputable, peer-reviewed journal Neurology in 2006. In April 2005, Prestwick Pharmaceuticals, the manufacturers of TBZ, announced that they had filed a New Drug Application with the FDA. The approval of this application was not expected to take long because Prestwick was granted "fast track" and orphan drug status for TBZ by the FDA. Orphan drug status is given to drugs that treat diseases that affect fewer than 200,000 people in the U.S., and the companies that produce them receive additional incentives to get them to market. In December 2007 the FDA Advisory Committee unanimously recommended Xenazine to be approved, and in August 2008 it was officially approved.
- T. Wang, 2/6/09
Further reading:
"FDA Approves First Drug for Treatment of Chorea in Huntington's Disease" 15 Aug 2008. (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01874.html) Press release from the FDA after Xenazine was approved in August 2008.
"FDA Approves Tetrabenazine." 17 Aug 2008. HD Lighthouse. ( http://hdlighthouse.org/showUpdate.php?p_articleNumber=589) An article from the HD Lighthouse contributing editor commenting on the FDA approval of tetrabenazine in August 2008.
Huntington Study Group. "Tetrabenazine as Antichorea Therapy in Huntington Disease." 2006. Neurology 66: 366-372 . This is the scientific article published by the Huntington Study Group discussing the TETRA-HD study and results.
Mikkelsen, B.O. "Tolerance of tetrabenazine during long-term treatment." 1983. ACTA Neurologica Scandinavica 68(1):57-60. This scientific article discusses side effects of tetrabenazine and explores the possibility of long-term use.
Miller, Marsha. "FDA Approves Tetrabenazine." 15 Aug 2008. Huntington's Disease Society of America. A concise article from the HDSA summarizing key facts about tetrabenazine.
Ondo, et al. "Tetrabenazine Treatment for Huntington's Disease-Associated Chorea." 2002. Clinical Neuropharmacology 25(6):300-302. This scientific article describes a study in which the efficacy in treating chorea and tolerability of tetrabenazine were tested on people with HD.
Pearson, S.J. and Reynolds, G.P. "Depletion of monoamine transmitters by tetrabenazine in brain tissue in Huntington's disease." 1988. Neuropharmacology 27(7): 717-719. This scientific article describes a study done on brain tissue of people who had HD. It shows how those treated with tetrabenazine had reduced dopamine in their brains.
Last Modified: 05/22/2009
An educational product of HOPES, not to be used in place of medical care. For more information about HOPES, click on the Logo.
To contact HOPES with comments or questions, click here.
