LOUISVILLE, Ky. – Based on a multicenter clinical trial that included participation at the University of Louisville, the U.S. Food and Drug Administration (FDA) approved SD-809 (deutetrabenazine) earlier this month. Deutetrabenazine is the second drug approved for use in the United States for the treatment of chorea associated with Huntington’s disease (HD). The other approved drug is tetrabenazine.
UofL was one of 34 sites in the United States, Canada and Australia that took part in the double-blind, placebo-controlled First-HD study. The Phase 3 clinical trial, conducted through the Huntington Study Group (HSG) and the University of Rochester’s Clinical Trial Coordination Center on behalf of Teva Pharmaceuticals, showed that deutetrabenazine significantly decreased chorea, the involuntary movements that many individuals with HD experience. The results were published in Journal of the American Medical Association, July 2016.
Most individuals with HD experience chorea during the course of the disease. Huntington’s disease is an autosomal-dominant, inherited disease that usually manifests in people in their 30s and 40s. The disease brings with it an array of symptoms besides chorea, including dystonia, cognitive problems, changes in personality and depression. Because HD is autosomal dominant, each child of a person with HD has a 50 percent chance of inheriting the genetic change that causes the disease.
“We are thankful to all patients who participated in this study and contributed towards this important step forward in the treatment of Huntington’s disease,” said Kathrin LaFaver, M.D., the Raymond Lee Lebby Chair in Parkinson’s Disease Research and director of the Movement Disorders Clinic at UofL. LaFaver, a member of the Huntington Study Group, coordinated the UofL trial site. Individuals interested in participating in clinical trials at UofL may browse the Clinical Trials Unit database.
Deutetrabenazine is related to tetrabenazine but incorporates a unique molecular structure that extends the drug’s presence in the bloodstream. The modification steadies the effects of the medication over a longer period of time.
Much of the clinical work that led to the approval of deutetrabenazine was carried out by the Huntington Study Group, a non-profit network of 400 Huntington’s disease experts from more than 100 medical centers throughout North America, Europe and Australia who are dedicated to seeking treatments that make a difference for people and families affected by the disease. For more information about HD, visit www.huntingtonstudygroup.org.
# # #