FDA Approves First Drug to Treat Huntington's Chorea
Xenazine reduces the involuntary movements that occur in Huntington's disease patients
MONDAY, Aug. 18 (HealthDay News) -- The U.S. Food and Drug Administration has approved Xenazine (tetrabenazine), the first drug for the treatment of chorea in people with Huntington's disease, according to a release issued by the FDA on Aug. 15.
Researchers performed a randomized, double-blind, placebo-controlled multicenter clinical trial to establish the safety and effectiveness of Xenazine in patients with Huntington's disease, a rare, inherited neurological disorder that affects about one in 10,000 people in the United States. Resulting from genetically programmed degeneration of brain cells, the disease causes jerky, involuntary movements (chorea), emotional difficulties and loss of intellectual faculties.
Xenazine reduces the amount of dopamine available to interact with certain nerve cells in the brain, which in turn decreases the involuntary movements associated with chorea. Among study patients, those treated with Xenazine had a significant improvement in chorea compared to patients treated with placebo, although the drug did result in a slight worsening in mood, cognition, rigidity and functional capacity. The most common side effects included insomnia, depression, drowsiness, restlessness and nausea.
"Xenazine represents hope for patients and families dealing with this difficult disease," Timothy Cote, M.D., director of the FDA's Office of Orphan Products Development, said in a statement. "For the first time, there is a treatment that can help patients with this disease gain some quality of life."
Xenazine is manufactured by Prestwick Pharmaceuticals, Inc. in Washington, D.C.