The FDA approved XENAZINE (tetrabenazine) from Prestwick Pharmaceuticals for the treatment of chorea associated with Huntington’s disease (HD). XENAZINE is expected to be available later this year.
“Until today, physicians and patients had no FDA-approved treatments for Huntington’s disease,” said Fred Marshall, MD, chief of the geriatric neurology unit at the University of Rochester. “Within a few months, for the first time, physicians will be able to offer these critically-ill patients a safe and effective medication to treat their chorea.”
A double-blind, placebo-controlled, Phase 3 study found that XENAZINE significantly reduced patients’ 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 Huntington’s disease patients.
XENAZINE has been available in a number of countries in Europe for more than 30 years.
Release date: August 15, 2008
Source: Prestwick Pharmaceuticals
Filed Under: Drug Discovery
