Xenazine is said to be the first and only FDA-approved treatment for any symptom of Huntington’s disease (HD) and is expected to be available later 2008.
A double-blind, placebo-controlled, Phase III study found that Xenazine significantly reduced patients’s chorea burden, improved global outcome scores, and was generally safe and well tolerated.
Xenazine will be marketed under an FDA-approved risk evaluation and mitigation strategy to decrease the risk of depression and suicidal ideation that may be associated with the drug, and are often pre-existing conditions in HD patients.
George Horner, III, president and CEO of Prestwick, said: “The approval of Xenazine is a huge advancement for the HD community, and we thank them for their contributions in helping to make this important product available in the US.”