Tetrabenazine is a highly selective and reversible centrally-acting dopamine depleting drug that works by inhibiting a molecule known as vesicular monoamine transporter 2 (VMAT2). Xenazine was approved by the FDA on August 15, 2008, for the treatment of chorea associated with Huntington's disease, based on the results of a double-blind, placebo-controlled, Phase 3 study that found Xenazine significantly reduced patients' chorea burden, improved global outcome scores, and was generally safe and well tolerated. Additional post-marketing preclinical studies further elucidating the safety profile of the product are being conducted. Tetrabenazine has been available in Europe for more than 30 years and in Canada since 1996.
The U.S. Food and Drug Administration has approved tetrabenazine, the first drug approved for use in the United States to treat Huntington's disease, a fatal, inherited neurodegenerative disorder for which there is no cure. The action comes about eight months after an advisory panel unanimously voted to advise FDA to make the medication available to treat the disease.
A drug used in some countries to treat the symptoms of Huntington's disease prevents death of brain cells in mice genetically engineered to mimic the hereditary condition, UT Southwestern Medical Center researchers have found.
The medication tetrabenazine cut down involuntary movement in patients with Huntington's disease on average by about 25 percent, with many patients experiencing a greater improvement, according to a study in the February 14 issue of the journal Neurology.
Researchers at Baylor College of Medicine in Houston are using botulinum toxin type A (Botox) to treat the neurological disorder, which can cause involuntary motor and vocal tics.